FDA grants tentative approval for daytime sleepiness treatment

The FDA has granted tentative approval to Lumryz, a once-at-bedtime oral treatment for excessive daytime sleepiness or cataplexy in adults with narcolepsy, Avadel Pharmaceuticals announced in a press release.

According to the biopharmaceutical company, final approval of Lumryz (sodium oxybate, Avadel) is pending disposition of a patent, which is currently listed in the FDA’s Orange Book. The extended-release oral suspension has met all required quality, safety and efficacy standards, the company said in the release.

“We have reached a critical milestone, as tentative approval confirms the safety profile and clinical efficacy of Lumryz for adults with narcolepsy,” Avadel CEO Greg Divis said in the release. “Tentative approval is an important regulatory step forward and indicates Lumryz could potentially be granted final approval in 11 months or less. We believe once-at-bedtime Lumryz offers the opportunity to positively transform the lives of oxybate eligible patients living with narcolepsy.”

In a phase 3 clinical trial, Lumryz reduced excessive daytime sleepiness and cataplexy attacks at three different doses compared with placebo, the release stated.

Avadel said it is currently following actions to potentially accelerate the FDA’s final approval decision and shorten the time between approval and launch of Lumryz, which the company anticipates could be on or before June 2023.