RARE Daily

FDA Grants Final Approval to Avadel’s Lumryz for Narcolepsy

May 2, 2023

Rare Daily Staff

The U.S. Food and Drug Administration has granted final approval to Avadel Pharmaceuticals’ Lumryz, as the first and only FDA approved, once-at-bedtime oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults 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,” said Greg Divis, CEO of Avadel. “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.”

Narcolepsy is a chronic neurological condition that impairs the brain’s ability to regulate the sleep-wake cycle. The condition affects approximately one in 2,000 people in the United States with the cardinal symptom of excessive daytime sleepiness. Additional symptoms can vary by person but may include disrupted nighttime sleep, a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), sleep paralysis, and hallucinations.

The FDA’s final approval of Lumryz was based on positive results from the pivotal phase 3 REST-ON clinical study completed in March 2020. In the REST-ON phase 3 trial, once-at-bedtime Lumryz demonstrated highly statistically significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints (Maintenance of Wakefulness Test, Clinical Global Impression-Improvement, and mean weekly cataplexy attacks) for all three doses evaluated, 6, 7.5 and 9 grams.

Lumryz has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. Lumryz is available only through a restricted program under a Risk Evaluation and Mitigation Strategy. Most common adverse reactions (incidence > 5 percent and greater than placebo) reported for all doses of Lumryz combined were nausea, dizziness, enuresis, headache, and vomiting.

Photo: Greg Divis, CEO of Avadel


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