Avadel Pharmaceuticals granted FDA final approval for narcolepsy drug
James Spargo | May 3, 2023 | News story | Medical Communications | FDA, FDA Approval, Neurology, avadel pharmaceuticals, narcolepsy, new drug approvals
Irish biopharmaceutical company Avadel Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted final approval and Orphan Drug Exclusivity (ODE) for its narcolepsy drug, aimed to reduce excessive daytime sleepiness (EDS).
Lumryz is an extended-release formulation of sodium oxybate intended for use in adults with cataplexy or EDS resulting from narcolepsy, given in a once-before-bed tablet.
Approval was given following results from the REST-ON phase 3 randomised, double-blind, placebo-controlled trial. Lumryz demonstrated statistically significant and clinically meaningful improvements for all three doses when compared to placebo. The three co-primary endpoints were: EDS; clinicians’ overall assessment of patient function (CGI-I); and cataplexy attacks.
Greg Divis, CEO of Avadel, commented, “Today’s landmark approval and receipt of ODE represents a major milestone for both Avadel and people living with narcolepsy. As we have heard from key stakeholders, previously approved narcolepsy therapies have the potential to disrupt sleep by either causing insomnia or through forced awakening during the middle of the night for their crucial second dose. Lumryz can now offer people with narcolepsy the opportunity for an uninterrupted night sleep while receiving the full benefit of their prescribed treatment in one single bedtime dose that addresses their symptoms of narcolepsy. We would like to thank the patients, caregivers, clinical trial investigators, healthcare providers and advocates who have tirelessly partnered with us throughout the drug development process and look forward to providing the narcolepsy community access to now approved Lumryz.”
James Spargo
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