Avadel Pharmaceuticals plc announced that Lumryz—an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy—is now commercially available.
“We are proud to announce that Lumryz is commercially available through both our RYZUP patient support program and our specialty pharmacy network for patients living with narcolepsy who have been waiting for over two decades for a single-dose treatment option that provides the opportunity for an uninterrupted night sleep,” says Greg Divis, CEO of Avadel, in a release. “Lumryz represents a new generation of oxybate treatment the FDA deemed clinically superior to all twice nightly oxybate treatments. The Avadel team is fully prepared to execute our commercial strategy and deliver Lumryz to the $3 billion-plus once-at-bedtime oxybate market.”
Lumryz is the first and only US Food and Drug Administration (FDA)-approved once-at-bedtime oxybate for people living with narcolepsy. The commercial strategy for Lumryz includes a patient support program, RYZUP, which is designed to provide support and education to patients who have been prescribed Lumryz and to assist them in gaining access to their medication, according to a release from Avadel.
Lumryz was granted FDA approval 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 (p<0.001) 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 was approved by the FDA on May 1 and was granted a seven-year period of Orphan Drug Exclusivity as a result of the FDA finding Lumryz to be clinically superior to all first-generation oxybate products. In particular, FDA found that Lumryz makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose.
Photo credit: Avadel Pharmaceuticals