Dec. 18 at 12:38 PM
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https://stocktwits.com/G101SPM/message/636178024
BRIEF: nnounced the completion of patient enrollment in REVITALYZ, a Phase 3 trial evaluating LUMRYZTM (sodium oxybate) extended-release oral suspension as a potential treatment for idiopathic hypersomnia (IH).
REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter Phase 3 trial designed to evaluate the efficacy and safety of LUMRYZ given as a once-at-bedtime dose in IH. The trial is evaluating study participants switching from immediate-release oxybates as well as those not currently taking oxybates.
“Idiopathic hypersomnia is a profoundly underserved, serious sleep disorder marked by extreme difficulty waking up, known as sleep inertia, and persistent, overwhelming daytime sleepiness,” said Richard K. Bogan, M.D., FCCP, FAASM, Principal of Bogan Sleep Consultants, LLC, and Associate Clinical Professor at the University of South Carolina School of Medicine. “People living with IH need additional treatments. With a therapeutic dose designed to cover the nocturnal sleep period due to its extended-release formulation, LUMRYZ could become a valuable option, if approved, for these patients.”
The primary objective of REVITALYZ is to demonstrate reduction in daytime sleepiness as measured by the primary endpoint, change in total score on the Epworth Sleepiness Scale (ESS) at Week 14. Secondary endpoints will evaluate the effect of LUMRYZ on additional efficacy parameters including patient and clinician impression of change, idiopathic hypersomnia severity, and a measure of the functional outcomes of sleep.
“Completion of enrollment in the REVITALYZ trial marks an important step forward for this community,” said Jennifer Gudeman, PharmD, Senior Vice President of Medical and Clinical Affairs at Avadel Pharmaceuticals. “The clinical benefits of LUMRYZ have already positively impacted the narcolepsy community, and we are optimistic our extended-release sodium oxybate has potential to be a meaningful treatment for the IH community as well, if approved by the FDA. We thank the patients and investigators who have enrolled in REVITALYZ for advancing this important research.”
