FDA approves Lumryz for cataplexy, excessive daytime sleepiness in adults with narcolepsy

Key takeaways:

• Lumryz is an extended-release, once-at-bedtime oral suspension for cataplexy or excessive daytime sleepiness in adults with narcolepsy.
• FDA approval was based on positive results from a phase 3 clinical trial.

The FDA has approved Lumryz, an extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

According to a press release from Avadel Pharmaceuticals, the approval makes Lumryz, which also was granted orphan drug exclusivity, the first and only FDA-approved once-at-bedtime oxybate for those with narcolepsy.

In addition, the FDA reported Lumryz to be clinically superior to twice-nightly oxybate products and granted Lumryz a 7-year market exclusivity, which began May 1, the date of approval.

“Today’s landmark approval and receipt of orphan drug exclusivity represents a major milestone for both Avadel and people living with narcolepsy,” Avadel CEO Greg Divis said in the release. “We would like to thank the patients, caregivers, clinical trial investigators, health care providers and advocates who have tirelessly partnered with us throughout the drug development process.”

FDA approval was based on positive results from the phase 3 REST-ON clinical study completed in March 2020. In the trial, Lumryz demonstrated statistically significant and clinically meaningful improvement compared with placebo across all three co-primary endpoints — Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks — at all three evaluated doses of 6 g, 7.5 g and 9 g, the release stated.

“People living with narcolepsy will finally have a new treatment option to manage [excessive daytime sleepiness] and cataplexy, and the fact that this new oxybate option allows for reduced dosing frequency is a game-changing advancement that shows Avadel’s commitment to understanding the patient experience,” Julie Flygare, JD, president and CEO of Project Sleep, said in the release.