Summary: Avadel Pharmaceuticals has commenced dosing in the REVITALYZ phase 3 study to evaluate the efficacy and safety of Lumryz, an extended-release sodium oxybate, as a treatment for idiopathic hypersomnia (IH). The study, involving approximately 150 adults, aims to assess the impact of Lumryz on reducing daytime sleepiness and other efficacy parameters over a 14-week period.
Key Takeaways:
- Study Objective: The REVITALYZ phase 3 study aims to demonstrate the efficacy and safety of Lumryz in reducing daytime sleepiness in patients with idiopathic hypersomnia.
- Study Design: This double-blind, placebo-controlled, randomized withdrawal study will enroll about 150 adults and includes an open-label extension portion.
- Significance: Lumryz, approved by the FDA for narcolepsy, is being tested for its potential to offer a once-at-bedtime treatment option for idiopathic hypersomnia.
Biopharmaceutical company Avadel Pharmaceuticals plc announced that the first patient has been dosed in REVITALYZ, a phase 3 study evaluating Lumryz as a potential treatment for idiopathic hypersomnia (IH).
REVITALYZ is a double-blind, placebo-controlled, randomized withdrawal, multicenter phase 3 study designed to evaluate the efficacy and safety of Lumryz, given as a once-at-bedtime dose, in IH. The study will enroll approximately 150 adults who are diagnosed with IH and includes an open-label extension portion. REVITALYZ enrollment is open for both participants switching from immediate-release oxybates and not currently taking oxybates.
“The potential of Lumryz to treat IH with only a single bedtime dose of extended-release sodium oxybate is promising, and the initiation of the phase 3 REVITALYZ study marks a significant step toward improving care for those living with IH,” says Richard K. Bogan, MD, FCCP, FAASM, principal of Bogan Sleep Consultants and associate clinical professor at University of South Carolina School of Medicine.
The primary objective of REVITALYZ is to demonstrate a reduction in daytime sleepiness as measured by the primary endpoint, change in total score of the Epworth Sleepiness Scale 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.
“Dosing the first patient in REVITALYZ is an important milestone for the IH community, which has been vocal in the need for more treatment options, particularly an extended-release form of oxybate that would ideally provide full nocturnal drug exposure in a single, once-at-bedtime dose,” says Jennifer Gudeman, PharmD, senior vice president of medical and clinical affairs of Avadel Pharmaceuticals, in a release. “We are committed to advancing this study and are emboldened by the excitement of experienced clinical trial sites’ participation, which reflects the critical unmet need in the current therapeutic landscape.”
Lumryz is an extended-release sodium oxybate medication approved by the US Food and Drug Administration on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
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