Avadel Pharmaceuticals has completed patient enrollment in the Phase 3 REVITALYZ trial for idiopathic hypersomnia.
The trial evaluates LUMRYZ™ (sodium oxybate) extended-release oral suspension as a potential treatment for IH.
The primary objective is to demonstrate a reduction in daytime sleepiness, a significant symptom of IH.
REVITALYZ Trial Completion
Enrollment in the Phase 3 REVITALYZ trial is a crucial milestone for Avadel Pharmaceuticals in addressing idiopathic hypersomnia.
LUMRYZ Extended-Release Formulation
LUMRYZ offers a once-at-bedtime dosing option that could be beneficial for patients with IH, if approved by the FDA.
FDA Approvals for LUMRYZ
LUMRYZ received FDA approval for both adult and pediatric patients with narcolepsy, showcasing its efficacy and clinical benefits.
- The completion of patient enrollment signifies progress in finding new treatments for idiopathic hypersomnia.
- LUMRYZ's extended-release formulation may offer significant advantages over existing treatments for sleep disorders.
- FDA approvals and Orphan Drug Exclusivity highlight the potential of LUMRYZ to address unmet medical needs in patients with narcolepsy and IH.
The successful enrollment in the REVITALYZ trial marks a positive step towards addressing the unmet needs of patients with idiopathic hypersomnia. Avadel Pharmaceuticals continues to drive innovation in the field of sleep disorders with the development of LUMRYZ.