Annual Golf Tournament and 24th Annual Race Raise More Than $34,000 for Families Living with Alzheimer’s and Related Dementia
SUMMERVILLE, S.C. – The ARK of South Carolina, dedicated to supporting families living with Alzheimer’s and Related Dementia (ADRD), recently hosted two successful events that raised over $34,000 for their essential programs and services. These events support individuals and families impacted by ADRD across various counties.
Annual Swing for The ARK Golf Tournament Raised $11,000
On Thursday, August 24, 2023, the Swing for The ARK Golf Tournament took place at Lake Marion Golf Course in Santee, SC. This annual event attracted nearly 100 golfers from multiple counties who came together to support the cause. The tournament, presented by Argos Cement, raised $11,000 to increase awareness and funding for programs assisting families living with ADRD in upper Dorchester and lower Orangeburg counties.
According to data from the University of South Carolina’s Arnold School of Public Health, more than 2,200 individuals live with ADRD in Dorchester County, with an additional 2,100 in Orangeburg County. These numbers represent a significant increase since the year 2000, with Dorchester County seeing a 313% rise and Orangeburg County experiencing a 132% increase in ADRD diagnoses. Remarkably, more than 70% of individuals diagnosed in both counties are cared for at home by family caregivers.
“Caregiving is demanding and can be overwhelming, and we are grateful to be able to offer support,” said Peg Lahmeyer, Executive Director of The ARK. “This event allows us to raise awareness in the community, so caregivers know they are not alone.”
The ARK of Harleyville, a satellite program of The ARK of SC, offers hope and relief to families living with dementia by providing comprehensive support services, including respite, caregiver education classes, community outreach, and support groups. The funds raised from the golf tournament will support The ARK of Harleyville’s programs, which offer support services to families in upper Dorchester and lower Orangeburg counties.
“It was a pleasure for the Argos Harleyville Cement Plant to support this golf tournament again this year,” said Vince Martin, Safety, Environmental, and Public Affairs Manager at Argos. “This was one of the largest tournaments we’ve ever sponsored, and everyone had a fantastic time. We look forward to supporting this golf tournament again in 2024.”
24th Annual Race for The ARK Generated $23,000
On August 26, 2023, The ARK of South Carolina held the 24th Annual McElveen Race for The ARK in historic downtown Summerville. With a turnout of more than 400 participants, this event raised $23,000 to benefit families living with Alzheimer’s and related dementia throughout the Lowcountry.
“We are grateful for the continued dedication and support from the Lowcountry community. These funds will help finance programs such as memory screenings, resource fairs, educational workshops, and support groups across Berkeley, Charleston, Colleton, Dorchester, and Orangeburg counties,” said Lahmeyer. “Additionally, the funds will support The ARK respite centers in Harleyville and Summerville and will significantly contribute to The ARK’s mission to provide comprehensive support services to families living with Alzheimer’s or related dementia in our five-county service area.”
Currently, more than 95,000 South Carolinians live with Alzheimer’s disease, and 11.5% of individuals aged 45 and older report subjective cognitive decline. The disease burden is carried by 197,000 family caregivers in South Carolina, who provide 296 million hours of unpaid care.
McElveen GMC returned as the title sponsor, and Trident Medical Center as the towel sponsor. The male overall winner was Jason McCormack with a time of 17:22, and the female overall winner was Kerry Robinson with a time of 21:21. The corporate challenge winners were reigning champions, AllCare Living Services. The youth challenge winners were Ridge Christian Academy. The independent team winners were Racers for Pacers.
The ARK looks forward to the 25th Annual Race for The ARK, scheduled for Saturday, August 24, 2024. This milestone event will be celebrated with an anniversary block party after the race. For more information, please visit www.thearkofsc.org or contact Allie Suber at events@thearkofsc.org.
ABOUT THE ARK OF SOUTH CAROLINA
Based in Summerville, SC, The ARK of SC is a local nonsectarian nonprofit outreach program providing hope and relief to families living with Alzheimer’s Disease or Related Dementia (ADRD). Support services include social respite care, support groups, education, caregiver consultations, resource referrals, and community development.
The ARK of Harleyville is a satellite program of The ARK of SC with support services, including social respite care, support groups, education, caregiver consultations, resource referrals, and community development.
South Carolina has been ranked as the best state for manufacturing in 2023 for the second consecutive year by Site Selection Group, LLC.
The ranking is based on factors such as workforce alignment, operating costs and geographic positioning, with South Carolina scoring ahead of North Carolina and Tennessee.
In a joyous and humble post on LinkedIn, Aaron Butner shared this post and images from the ribbon cutting. A proud moment for Boone Hall Plantation and the Mount Pleasant, SC community.
In 1681, Major John Boone & his wife Elizabeth, founded the plantation of Boone Hall.
In 2023, the farm is still in operation and telling the story of American history.
Yesterday, the ribbon was cut on the newly renovated Cotton Gin House! This structure was built in the 1850’s and it is gorgeous!
What Jim Westerhold and many others have done to protect this gem of American history is truly special. Conservation work to protect this property from future development was done by many folk, both public & private. Thanks to Helen Turner Hill, Duane Parrish, and Will Haynie for helping keep this national treasure safe! Willie would be proud of y’all!
Bring your family out to the farm! Learn about the history of America and see some of the most beautiful scenes from early American history! Zoom in on some of the photos below to read more about Boone Hall!
Starting September outside Charleston, then Orlando, Crush Yard eyes 50 Southeast markets.
CHARLESTON, S.C., Sept. 13, 2023 /PRNewswire/ — When the first Crush Yard opens outside Charleston (Mount Pleasant, SC) this month, it will introduce a new concept in eatertainment – a membership experience with priority pickleball court bookings and gourmet self-service via a custom app.
Crush Yard targets a widening hunger for pickleball in the Sun Belt, where supply lags demand. There are considerably more players than facilities – 175 players for every court – and enthusiasts are growing by the day.
Unlike other eatertainment destinations built solely for eating and drinking around pickleball, golf, and arcade games, Crush Yard’s foundation is a sports club. Director of Pickleball and Head Pro Dan Levine, an ITPTA Certified Level II Pickleball Pro, will give private and group lessons, and run camps, leagues, and tournaments for members.
Crush Members get private open-play hours every day (5:00 – 11:00 AM) and priority access to teaching and tournaments. They also get access to Matt “McNasty” Manasse, “Pickleball Coach to the Stars” who coaches such Hollywood stars as Emma Watson and Larry David. Manasse is the chain’s Chief Brand Ambassador.
“Access is the principal luxury for pickleball enthusiasts,” said Andrew Ladden, CMO of Crush Yard. “So, our business starts with memberships. That gives us a dedicated base of players who are coming day in, day out. We will also host events making Crush Yard a travel destination for those dedicated to the growing sport.”
Everyone who comes to Crush Yard gets access to gourmet comfort food created by chef Brandon Buck, coffee fromOne Nation Coffee, and micro brews fromHoly City Brewing. In addition to pouring One Nation blends, they’ve also created Crush Brew which customers can enjoy at the restaurant or buy grounds to take home. Holy City Brewing has brewed a special ale for Crush Yard called Dinker’s Delight – a wheat variety hopped with citrus and fermented with orange purée.
Everything is available on an extensive, proprietary self-serve app that replaces servers to speed up delivery. An entry-level Yard Membership gives repeat visitors unlimited soft drinks, credits on food purchases, and reduced fees on court reservations and equipment rentals.
The 40,000 square-foot facility occupies an existing building that previously housed The South Carolina State Armory. The Orlando facility, coming in November, is being fashioned from a former Bed Bath and Beyond building. Crush Yard makes it a point to develop in abandoned mail and retail locations to speed development and promote sustainability in communities.
“It’s a competitive advantage for us to use existing locations,” said Ladden. “We can get a Crush Yard operational in 10 months, instead of the typical two years it takes to build from the ground up. It costs us, and our communities, far less in the end.”
National security consulting company achieves new partnership with Microsoft AI Cloud
CHARLESTON, S.C. – September 13, 2023 –Ignite Digital Services, an operational consulting company serving the national security sector, announced its latest credential as part of the company’s growing suite of technology solutions – becoming a Microsoft AI Cloud Partner. This designation, formalized July 31, 2023, brings clients the very latest in cloud-based artificial intelligence (AI) backed by leading software provider Microsoft. As a Microsoft AI Cloud Partner, Ignite Digital is qualified to deploy a wide range of technology solutions tailored to clients’ specific needs.
“Our team at Ignite Digital deploys strategic solves to enhance the efforts of the public and defense sectors,” shares Marc Murphy, CEO of Ignite Digital. “With our deep industry expertise and an impressive list of product partnerships, including our latest Microsoft’s AI Cloud Partner distinction, we offer our clients the best of today’s emerging and leading technologies.
Prioritizing best-in-class software technology solution partnerships allows Ignite Digital to develop, build and maintain cutting-edge products that serve the diverse needs of its clients. Under the company’s Certified to Serve commitment, Ignite Digital maximizes the potential of these partnerships by incorporating comprehensive training and ensuring qualified support structures.
Ignite Digital received its AI Cloud Partner status after meeting the program criteria measuring performance, skilling and customer growth capabilities. The designation allows the company to leverage Microsoft’s portfolio of operating systems, productivity suites, cloud services, and development tools. Ignite Digital also holds certifications with UiPath and Archer IRM, among others.
“The value of technology solutions for the public sector is clear, and I’m proud to see how this team strives to bring a high level of value-driven, mission-critical service to our client base,” adds Murphy.
About Ignite Digital Services
Ignite Digital Services harnesses the power of digital technology and effective business solutions to ignite digital transformations for the national security industry. With a keen focus on purposeful results and innovative capabilities, the company offers unparalleled value that supports mission-critical initiatives. Learn more about Ignite Digital Services at ignite-digital.com.
TEL AVIV, Israel, Sept. 12, 2023 /PRNewswire/ — ZOOZ Power (TASE: ZOOZ), a leading provider of flywheel-based power boosting solutions for the EV charging infrastructure market, announces the successful installation and initiation of a fast-charging station for electric vehicles (EVs), supported by ZOOZ’s power booster, the ZOOZTER™-100, at a Scotchman gas station and convenience store, operated by a subsidiary of ARKO Corp., in Rock Hill, South Carolina.
ZOOZTER™-100 enables ultra-fast charging of electric vehicles, while overcoming the grid’s power-limitations (PRNewsfoto/ZOOZ Power)
This fast charging station, supported by the ZOOZTER™-100, ZOOZ’s innovative kinetic (flywheel-based) Power Booster, was established and will be operated as part of a joint pilot with ARKO Corp. one of the largest convenience store operators in the US, and in cooperation with ABM, a leader in eMobility design, installation, and maintenance solutions.
ZOOZ Power and its partners have successfully completed the Site Acceptance Tests (SAT) on Thursday, September 7th, 2023, and a run-in period of several weeks began. During this period, the charging station will operate commercially and will allow fast charging services to owners of electric vehicles visiting the site, while the Company and its partners will monitor the site, ensuring proper operation of the charging station.
Boaz Weizer, ZOOZ Power’s Chief Executive Officer, commented: “We are proud to have the first commercially operational site in North America and demonstrate our innovative Power Booster, the ZOOZTER™-100, enabling ultra-fast charging of electric vehicles, while overcoming the grid’s power-limitations. This is a significant milestone as we accelerate our penetration into the U.S. market. I would like to congratulate the wonderful ZOOZ team and to thank our partners at ARKO Corp., one of the largest U.S. convenience store operators, and ABM, who worked with us over the last year to achieve this milestone.
We recently announced a pilot installation at New York’s LaGuardia Airport and additional pilot projects with the New York Power Authority and a large car rental agency. Our collaboration with reputable large-scale U.S.-based companies strengthens our position as the industry’s trailblazer.”
In the coming years, the U.S. mobility market is expected to experience an accelerated adoption of electric vehicles, supported by the tailwind of the federal government plans to push forward the transition to electric vehicles and enhance the establishment of widespread charging infrastructure for EVs.
ZOOZ Power intends to use the site, in Rock Hill, SC, for demonstrations of a first-of-its-kind charging station in North America, where the Company will be presenting its “green” kinetic Power Booster, the ZOOZTER™-100, geared to enable ultra-fast charging, even in locations where the grid is power-constrained.
Forward Looking Statements
The information set forth above regarding the duration of the Pilot, success of the Pilot, and/or sales or agreements that may be based on the Pilot and the expected accelerated adoption of electric vehicles in the US mobility market in the coming years constitutes “Forward-looking Information” as defined in the Securities Law, 5728-1968, based on the Company’s assessments of future developments and events whose date of occurrence, if any, is uncertain and is not under the control of the Company. These assessments may not materialize, in whole or in part, or may be realized differently than assessed by the Company as a result of various factors, including the realization of any of the Company’s risk factors listed in section 1.3.36 in the chapter describing the corporation’s business in the Company’s 2022 Report.
About ZOOZ Power Ltd.
ZOOZ is a leading provider of flywheel-based power-boosting solutions enabling ultra-green, ultra-fast electric vehicle charging anywhere. ZOOZ is committed to eliminating range anxiety and helping to accelerate the mass adoption of electric vehicles around the world. ZOOZ’s goal is to enable the vast roll-out of cost-effective ultra-fast charging infrastructure while overcoming existing grid limitations. Based on its innovative flywheel technology, ZOOZ pioneers the use of kinetic energy storage, as a power boosting solution supporting ultra-fast EV charging infrastructure. ZOOZ’s products are built with longevity and the environment in mind, helping its global customers and partners create highly sustainable, reliable, long-lasting, and cost-effective fast-charging solutions.
ZOOZ Power is in the process of a business combination with Keyarch, a special purpose acquisition company. Following the closing of the transaction, ZOOZ is expected to be publicly listed on Nasdaq under the symbol “ZOOZ” and will remain listed on the Tel Aviv Stock Exchange (“TASE”). After the closing, the merged company will continue to be called ZOOZ Power Ltd. The closing is expected to occur in the fourth quarter of 2023 and is subject to applicable closing conditions.
With beaches, historic charm and an amazing restaurant scene, the city of Charleston is one of the hottest tourist destinations in the world – a boon for College of Charlestonhospitality and tourism management students. The city provides an abundance of hands-on learning opportunities with access to some of the best hospitality organizations in the industry, including Beemok Hospitality Collection.
As a company committed to fostering the growth of future hospitality leaders, the Charleston-based luxury hospitality company – whose portfolio includes The Charleston Place, Sorelle, The Riviera, Credit One Stadium and The Cooper – has partnered with the School of Business to establish a scholarship and leadership program for hospitality and tourism management majors.
“The hospitality industry was significantly impacted due to the pandemic, so our goal with these programs is to inspire future generations of leaders by exposing them to the numerous opportunities available when they choose a career in hospitality,” says Casey Lavin, BHC president. “We believe in the power of purpose-driven hospitality and creating meaningful ways for people to connect and share extraordinary experiences, and we are excited to share our passion with these exceptional students.”
“I am really pleased that the College of Charleston has formed this partnership with BHC,” says CofC President Andrew T. Hsu, “because their mission aligns closely with the best practices our faculty teach and instill in our hospitality and tourism management graduates.”
Offered in the fall or spring semester of students’ junior year, the new BHC Service Leadership Scholars Program aims to develop talented hospitality and tourism management majors, minors and concentrations. BHC Service Leadership Scholars will receive personal assessment, professional development, mentoring and exclusive access to a variety of leaders in the hospitality industry both locally and around the world. The program will focus on effective communications, problem solving, synthesis, and ethical and global awareness.
To join the program, students undergo a rigorous application and interview process. Six students have been selected as BHC Service Leadership Scholars for the fall 2023 semester and six for the spring 2024 semester.
In addition, every academic year beginning in the fall of 2024, six declared hospitality and tourism management majors with a proven interest in community service will be awarded a $5,000 Beemok Hospitality Collection Scholarship. Throughout the tenure of the scholarship, the students will be encouraged to meet with BHC representatives to learn about the art of hospitality.
“The BHC Service Leadership Scholars Program and Beemok Hospitality Collection Scholarship are a testament to the power of collaboration between academia and industry,” says Paul Schwager, dean of the College of Charleston School of Business. “Our students will benefit from enriching experiences beyond the classroom, and the business community will directly benefit. We thank Beemok Hospitality Collection for its generous support of this important program that will guarantee student success.”
Above: Members of the Beemok Hospitality Collection with the 2023–24 Beemok Service Leadership Scholars at the fall kickoff retreat at The Charleston Place (l–r): Casey Lavin, BHC president and CEO; LeeAnn Boissière-Rigault, director of people and culture, The Charleston Place; Becky Hubbard, managing director, The Charleston Place; BHC Service Leadership Scholars Sara O’Brien, Holly Hutchinson and Lydia Johnson; Frank Fredericks, CofC adjunct professor and executive advisor of the BHC Service Leadership Program; BHC Service Leadership Scholars Emma Peters, Annie Burton, Bethany Brown and MiaBella Provenzano; Jeremy Clement, CofC senior instructor and intern coordinator and director of the BHC Service Leadership Program; BHC Service Leadership Scholars Julia Schultz, Caroline Orchard, Kylie Fender, Aubrianna Boland and Annaliesse Cantera
Six presentations demonstrated Jazz’s commitment to providing solutions for people living with difficult-to-treat sleep disorders
Review of multiple clinical trials provided a comprehensive analysis showing that oxybate improves sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy, independent of once- or twice-nightly dosing
DUBLIN, Sept. 11, 2023 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that six abstracts presenting data from across its sleep medicine portfolio were featured at the 36th annual Psych Congress, held September 6-10, 2023. One of the accepted abstracts provided a comprehensive review of clinical data that assessed the impact of oxybate on sleep quality, sleep architecture and measures of disrupted nighttime sleep in narcolepsy. Oxybate is the active ingredient in Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution.
This review encompassed key data from five clinical studies that evaluated all high-sodium oxybates, fixed-dose and twice-nightly administrations, in both oxybate-experienced patients and those who had not undergone prior treatment. The review found that oxybate improved measures of sleep architecture and disrupted nighttime sleep in narcolepsy patients, independent of dosing regimen or prior oxybate experience.
“These compelling data add to the growing body of literature that looks at the effects of oxybate therapy in terms of sleep quality, sleep architecture and daytime function,” said Richard K. Bogan, MD, FCCP, FAASM, associate clinical professor at the University of South Carolina School of Medicine and Medical University of South Carolina in Charleston, South Carolina. “The review found that there was no significant difference in the improvement of sleep quality between oxybate dosing schedules. This is an important endpoint, as many patients utilize the twice-nightly dosing to individualize treatment of their sleep disorder.”
Other highlights from Psych Congress 2023 included:
In narcolepsy:
A subgroup analysis from the Phase 3 study of Xywav in adults with narcolepsy, which found that the treatment’s safety and efficacy were similar in those with and without psychiatric comorbidities, including depression and anxiety, and that there were no signals for the occurrence of new psychiatric disorders in either subgroup.
In idiopathic hypersomnia:
Two posters featuring results from online surveys of U.S. physicians and patients living with idiopathic hypersomnia that provided insights into physicians’ understanding of the disorder as well as the diagnostic journey and quality of life impact for patients.
“Idiopathic hypersomnia has a profound impact on those who live with this debilitating sleep disorder,” said Kelvin Tan, MBBCh, MRCPCH, senior vice president and chief medical officer of Jazz Pharmaceuticals. “Jazz has a longstanding legacy in sleep medicine, and we are proud of our research into new treatment approaches that may benefit patients living with serious sleep conditions such as idiopathic hypersomnia and narcolepsy. We are presenting multiple datasets that show the significant impact that idiopathic hypersomnia has on patient quality of life, which highlights the need for effective treatment options.”
The Psych Congress 2023 presentations are available on-demand through the conference mobile application. Abstracts and posters will also be published on HMP Global’s Psychiatry & Behavioral Health Learning Network 30-60 days after the event ends.
A full list of Jazz presentations follows below:
Presentation Title
Lead Author
Poster Number
Narcolepsy Data
Safety and Efficacy of Low-Sodium Oxybate in Participants With Narcolepsy With and Without Psychiatric Comorbidities: Subgroup Analysis of a Phase 3 Clinical Trial
C Chepke
Poster board number: 84
Effects of Oxybate on Sleep, Sleep Architecture, and Disrupted Nighttime Sleep
T Roth
Poster board number: 150
Idiopathic Hypersomnia Data
Diagnosed Prevalence of Idiopathic Hypersomnia Among Adults in the United States
R Saad
Poster board number: 74
Cardiovascular Burden of Patients Diagnosed With Idiopathic Hypersomnia: Real-World Idiopathic Hypersomnia Total Health Model (CV-RHYTHM)
R Saad
Poster board number: 75
Patient Perspective on Idiopathic Hypersomnia: Impact on Quality of Life and Satisfaction With the Diagnostic Process and Management
M Whalen
Poster board number: 164
Physician Perspective on Idiopathic Hypersomnia: Awareness, Diagnosis, and Impact on Patients
M Whalen
Poster board number: 165
About Narcolepsy Narcolepsy is a chronic, debilitating neurologic sleep disorder characterized by excessive daytime sleepiness (the inability to stay awake and alert during the day resulting in the irrepressible need to sleep or unplanned lapses into sleep or drowsiness), or EDS, and an inability to regulate sleep-wake cycles normally.1 Patients with EDS due to narcolepsy experience sleep attacks and, despite fighting the urge to sleep, may unintentionally fall asleep for short periods.2,3 These sleep attacks may happen at inappropriate or potentially dangerous times such as during driving, cycling, eating, or mid-conversation.4
There is no cure for narcolepsy, therefore EDS is lifelong and has a substantial negative impact on a person’s ability to function psychologically, socially and professionally.5 Patients with narcolepsy are at increased risk for hypertension, cardiometabolic morbidity, stroke, myocardial infarction, heart failure, cardiac arrest, and death.6,7,8,9 As narcolepsy is a chronic condition that requires lifelong, nightly treatment, early access to an effective, low-sodium treatment can transform lives and reduce the impact of narcolepsy on a person’s physical and mental health.5
About Idiopathic Hypersomnia Idiopathic hypersomnia is an often debilitating, neurologic sleep disorder that goes beyond chronic excessive daytime sleepiness.10,11,12,13 Idiopathic hypersomnia is a 24-hour sleep disorder, and symptoms may include a prolonged but non-restorative main (nighttime) sleep episode of more than 9 hours, or a sleep duration of 11 hours or longer over a 24-hour period; severe sleep inertia (prolonged difficulty waking, with frequent reentries into sleep, confusion, and irritability); cognitive impairment; long and unrefreshing naps; and brain fog, or the inability to focus for long periods of time.10,11,12,13,14 Although there are overlapping clinical features with narcolepsy, idiopathic hypersomnia is a condition with its own specific diagnostic criteria.13,15
Idiopathic hypersomnia is a debilitating illness that can significantly affect social, educational, and occupational functioning.16,17 In the U.S., approximately 37,000 adult patients have been diagnosed with idiopathic hypersomnia and are actively seeking healthcare.18 This low number of people may be due to the many difficulties in identifying and diagnosing idiopathic hypersomnia, as well as distinguishing it from other similar sleep disorders. It is estimated that far fewer patients are currently receiving pharmacological treatment for their idiopathic hypersomnia.18,19,20,21
About Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution Xywav is a low-sodium oxybate approved by the U.S. Food and Drug Administration (FDA) for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav in June 2021 for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. The Office of Orphan Product Development (OOPD) at the FDA also published its summary of clinical superiority findings for Xywav for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy by means of greater cardiovascular safety compared to Xyrem® (sodium oxybate) oral solution. The decision of the OOPD is based on the FDA findings that Xywav provides a greatly reduced chronic sodium burden compared to Xyrem. Xywav has 131 mg of sodium at the maximum recommended nightly dose. Xywav is comprised of a unique composition of cations resulting in 92% less sodium, or a reduction of approximately 1,000 to 1,500 mg/night. Xywav is the only low-sodium oxybate therapy approved by the FDA, and the only oxybate that does not carry a warning in the label related to high sodium intake.
Xywav is also the first and only U.S. FDA-approved treatment option for idiopathic hypersomnia in adults. The FDA recognized seven years of Orphan Drug Exclusivity for Xywav in December 2021 for the treatment of idiopathic hypersomnia in adults. Xywav is the only FDA-approved treatment studied across the multiple symptoms of idiopathic hypersomnia, such as excessive daytime sleepiness, sleep inertia (severe grogginess or confusion when waking up), long sleep duration, and cognitive impairment. Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.
The exact mechanism of action of Xywav in the treatment of adults with idiopathic hypersomnia and of cataplexy and EDS in narcolepsy is unknown. It is hypothesized that the therapeutic effects of Xywav are mediated through GABAB actions during sleep at noradrenergic and dopaminergic neurons, as well as thalamocortical neurons.22 The U.S. Drug Enforcement Agency (DEA) has designated Xywav as a Schedule III medicine. The DEA defines Schedule III drugs, substances, or chemicals as drugs with a moderate to low potential for physical and psychological dependence.22,23 Because of the risks of central nervous system (CNS) depression and abuse and misuse, Xywav is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the XYWAV and XYREM REMS.
Important Safety Information for Xywav
WARNING: Taking XYWAV with other central nervous system (CNS) depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope), and death.
The active ingredient of XYWAV is a form of gamma-hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death. Call your doctor right away if you or your child has any of these serious side effects.
Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child’s prescription for XYWAV filled.
Do not take XYWAV if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drinks alcohol, or has a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep XYWAV in a safe place to prevent abuse and misuse. Selling or giving away XYWAV may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Anyone who takes XYWAV should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYWAV. Those activities should not be done until you know how XYWAV affects you or your child.
XYWAV can cause serious side effects, including the following:
Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYWAV.
Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness, or difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself or themselves. Call your doctor right away if you have or your child has symptoms of mental health problems or a change in weight or appetite.
Sleepwalking. XYWAV can cause sleepwalking, which can cause injuries. Call your doctor if this occurs.
The most common side effects of XYWAV in adults include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, excessive sweating (hyperhidrosis), vomiting, diarrhea, dry mouth, parasomnia (a sleep disorder that can include abnormal dreams, abnormal rapid eye movement (REM) sleep, sleep paralysis, sleep talking, sleep terror, sleep-related eating disorder, sleep walking, and other abnormal sleep-related events), somnolence, fatigue, and tremor.
The most common side effects of XYREM (which also contains oxybate like XYWAV) in children include nausea, bedwetting, vomiting, headache, weight decrease, decreased appetite, dizziness, and sleepwalking.
XYWAV can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYWAV.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Xyrem® (sodium oxybate) oral solution Xyrem oral solution, CIII, is a product approved by the U.S. Food and Drug Administration (FDA) for both cataplexy and excessive daytime sleepiness in narcolepsy in adult and pediatric patients ages 7 and older.24Xyrem may only be dispensed to patients enrolled in the XYWAV and XYREM REMS. Xyrem was first approved in the U.S. in 2002, based on clinical trial data in adults.
Important Safety Information for Xyrem
WARNING: Taking XYREM with other CNS depressants such as medicines used to make you or your child fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol, or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), dizziness (syncope), and death.
XYREM is a form of gamma hydroxybutyrate (GHB). Abuse or misuse of illegal GHB alone or with other drugs that cause changes in alertness (or consciousness) has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma, and death.
Because of these risks, you have to go through the XYWAV and XYREM REMS to have your or your child’s prescription for XYREM filled.
Do not take XYREM if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol, or have a rare problem called succinic semialdehyde dehydrogenase deficiency.
Keep XYREM in a safe place to prevent abuse and misuse. Selling or giving away XYREM may harm others and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Anyone who takes XYREM should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery, or flying an airplane, for at least 6 hours after taking XYREM. Those activities should not be done until you know how XYREM affects you or your child.
XYREM can cause serious side effects, including the following:
Breathing problems, including slower breathing, trouble breathing, and/or short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use XYREM.
Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, or thoughts of killing yourself or trying to kill yourself. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you have or your child has symptoms of mental health problems.
Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child starts sleepwalking. Your doctor should check you or your child.
Tell your doctor if you are or your child is on a salt-restricted diet or if you have or your child has high blood pressure, heart failure, or kidney problems. XYREM contains a lot of sodium (salt) and may not be right for you or your child.
The most common side effects of XYREM include nausea, somnolence, dizziness, vomiting, bedwetting, and tremor (in adults). In pediatric patients, headache, decreased appetite, and weight decrease were also common. Your side effects may increase when you take higher doses of XYREM. XYREM can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of XYREM.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
About Jazz Pharmaceuticals plc Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. Within these therapeutic areas, we are identifying new options for patients by actively exploring small molecules and biologics, and through innovative delivery technologies and cannabinoid science. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. Please visit www.jazzpharmaceuticals.com for more information.
Breakfast and Brunch Deliver Flavor for All at The Beach
MYRTLE BEACH, S.C., Sept. 10, 2023 /PRNewswire/ — With gloriously sunny days and balmy nights well into the fall, Myrtle Beach, South Carolina is the ideal place to treat yourself to a sun-soaked autumnal escape and keep those vacation vibes alive. There’s no better way to start your fall getaway at The Beach than with a hearty morning meal to keep you fueled up and ready for adventure. The Grand Strand is home to a burgeoning brunch scene that rivals many a culinary mecca.
With two locations along Myrtle Beach’s Grand Strand, Blueberry’s Grill serves up breakfast with delicious and unique dishes made from locally sourced ingredients. Credit: Visit Myrtle Beach
“The myriad of top-notch and delectable culinary offerings in Myrtle Beach from breakfast to brunch and beyond allows visitors to sample some of the region’s most iconic and unique dishes while traveling along the Grand Strand’s 60 miles of sunny coastline,” said Karen Riordan, President and CEO of Visit Myrtle Beach. “With new restaurant concepts being launched every month and an impressive line-up of food-related events showcasing seasonal cuisine, The Beach offers the perfect balance of stunning fall weather and flavorful fare for all.”
Here are just a few tasty breakfast and brunch ideas to fuel your next Myrtle Beach getaway. The sweet and savory must-have dishes below – alongside the full menus at each scrumptious spot – will have your tastebuds summering all the way to the next solstice:
Sweet Treats:
Milk & Honey Coffee Café (351 US 17 Business N, Surfside Beach): Two-time winner of “Guy’s Grocery Games” and “The Big Brunch” contestant Chef Mason Zeglen opened this Grand Strand oasis, offering up chill morning vibes, signature coffees, fresh baked pastries & more. Menu must-try: Espresso Tonic and Pistachio Cardamom Knot
Benjamin’s Bakery (810 3rd Ave S, Surfside Beach): From house-roasted coffee to an array of pastries, bagels and mouth watering sandwiches, this family-owned business is a popular staple. Menu must-try: Dossant (a donut-croissant, not to be confused with the “cronut”)
The Trestle Bakery & Café (308 N Main St, Conway): Located steps from the riverwalk and draped by Live Oaks in the historic downtown of Conway, Trestle is a local favorite serving up freshly baked bread and an array of breakfast treats. Menu must-try: Fresh Trestle Donuts
Croissants Bistro & Bakery (8014 North Kings Hwy. Myrtle Beach): Croissants’ mouthwatering menu offers an eclectic variety of food satisfying simple and complex palettes alike. Menu must-try: Bananas Foster French Toast
Savory Favorites:
Mimosas (7430 North Kings Hwy, Myrtle Beach): Opened this June, this stylish restaurant features a large outdoor dining area, and a specialty brunch menu. Menu must-try: Fried Lobster and Waffles
Zardin (3077 Howard Ave., Myrtle Beach): An upscale, healthy eatery in Market Common with a brunch menu that holds the perfect balance of delicious and nutritious. Menu must-try: Smoked Salmon Avocado Toast
Blueberry’s Grill (Multiple locations): With two locations to choose from along the Grand Strand, they serve up an elevated food experience with delicious and unique dishes made from locally sourced ingredients. Menu must-try: Crab Cake Benedict
Winna’s Kitchen (819 Main Street, Myrtle Beach): Blocks away from Myrtle Beach’s famous boardwalk, Winna’s is part of Myrtle Beach’s growing Arts and Innovation district. Enjoy an ever-evolving, Southern-eclectic menu with seasonal offerings within the revitalized downtown building. Menu must-try: Bacon & Egg Fried Rice
Check out additional information on the most important meal of the day in Myrtle Beach here, and don’t miss the fall foodie festivities here!
For additional fall getaway inspiration, check out Myrtle Beach’s Fall Vacation Guide.
About Myrtle Beach, S.C. Myrtle Beach isn’t just a beach. It’s The Beach. Popularly known as the Grand Strand, Myrtle Beach is one destination made up of 14 unique communities that stretch 60 miles along the northeast coast of South Carolina. Families, couples and those in search of a warm welcome will find more than just a day at The Beach when they come together to connect and enjoy vibrant entertainment and family attractions, including world-class golf, shopping and fresh coastal Carolina cuisine. From the moment you arrive, you’ll find you belong at The Beach – Myrtle Beach, South Carolina. For additional information on tourism offerings in the Myrtle Beach area, visit www.visitmyrtlebeach.com or call (888) Myrtle-1.
by 
