If you’ve missed any of the latest news we’ve shared through our social media this month, don’t worry! Get up to date with this edition of “In Case You Missed It!”
- WELCOME!: Dr. Anne Marie Morse joins the HF Medical Advisory Board
- BONUS CONTENT: 2 new videos released from recent HF Conference
- NOW RECRUITING: Pediatric narcolepsy survey study seeking participants
- INTERESTING READ: Learn how viruses can change sleeping patterns
Don’t worry if you’ve missed anything. We’ve got you covered!
HYPERSOMNIA FOUNDATION WELCOMES NEW MEMBER TO MEDICAL ADVISORY BOARD
We are pleased to welcome Dr. Anne Marie Morse as a new member of the Hypersomnia Foundation’s Medical Advisory Board.
Dr. Morse is a board-certified and fellowship-trained pediatric neurologist. She currently serves as the Director of Child Neurology and Pediatric Sleep Medicine at Geisinger, Janet Weis Children’s Hospital. Her clinical interests include sleep-wake disorders in neurologic disease, narcolepsy, hypersomnia disorders, and neuroimmunology. Her research interests include sleep-wake disorders in neurologic disease, hypersomnia disorders, and sleep-wake disorder phenotyping.
Learn more about Dr. Morse and the other distinguished members of our Medical Advisory Board.
“An Interview With Avadel Pharmaceuticals”—Andrew Powell, Hypersomnia Foundation’s Industry Outreach Officer, speaks with Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs for Avadel Pharmaceuticals. Dr. Gudeman discusses Avadel’s history of focusing medicine delivery to historically unmet medical needs, their creation of “plain language summaries” so study and clinical trial details can reach a broader audience, and the importance of always listening to patients, and recognizing clinical trial participants as “medical heroes.” Dr. Gudeman’s 12-minute interview can be seen HERE.
“An Interview With Jazz Pharmaceuticals”—Andrew Powell, Hypersomnia Foundation’s Industry Outreach Officer, speaks with Dr. Kelvin Tan, Chief Medical Officer for Jazz Pharmaceuticals. They discuss the importance of understanding and meeting patients’ needs, Jazz Pharma’s emphasis on getting medications to the public as soon as possible, and Jazz’s dedication to partnering with patient advocacy organizations. Watch Dr. Tan’s 15-minute interview HERE.
NOW RECRUITING—STUDY TO DEVELOP A PEDIATRIC NARCOLEPSY PATIENT REPORTED OUTCOMES SCALE
Narcolepsy symptoms in children and adolescents extend beyond sleepiness alone and commonly affect academic function, social relationships, mood, and sleep. In order to develop an outcomes scale that reflects values and experiences of kids with pediatric narcolepsy, a group of researchers from Boston Children’s Hospital, Stanford University, Geisinger Medical Center, The Hospital for Sick Children, and National Jewish Health are testing a survey among children between 9 to 17 years with a confirmed narcolepsy diagnosis. Participation requires permitting confirmation of diagnosis and completion of online surveys. As a thank you, participants completing surveys will be given a $50 gift card.
For more information, visit our “Currently Recruiting Studies”.
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Lumryz, also known as FT218, by Avadel Pharmaceuticals. Lumryz is a once-at-bedtime investigational formulation of a long-acting sodium oxybate (the same class of medicine as Xyrem and Xywav) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
The FDA grants “tentative” approval of drugs until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product. Tentative approval indicates that Lumryz has met all required quality, safety, and efficacy standards necessary for approval in the United States.
“We have reached a critical milestone, as tentative approval confirms the safety profile and clinical efficacy of Lumryz for adults with narcolepsy,” says Greg Divis, CEO at Avadel Pharmaceuticals, in a release. “Tentative approval is an important regulatory step forward and indicates LUMRYZ could potentially be granted final approval in 11 months or less.”
Read the complete announcement in a recent online edition of “Sleep Review” magazine.
Avadel has also released a community announcement regarding Lumryz, which can be found HERE.
HOW VIRUSES CAN CHANGE OUR SLEEPING PATTERNS
As COVID infections have increased, there are more reports of people experiencing poor sleep during and following COVID infection. Some people report insomnia symptoms, commonly referred to as “coronasomnia” or “COVID insomnia”, where they struggle to fall or stay asleep. Others report feeling constantly fatigued, and seemingly can’t get enough sleep, with this sometimes being referred to as “long COVID”.
Why is sleep impacted by COVID infections, and why do impacts differ so much between individuals? Learn more in a recent article in the online edition of “Sleep Review” magazine.