Avadel Pharmaceuticals announces final FDA approval of LUMRYZ

Avadel Pharmaceuticals announced that the U.S. Food & Drug Administration has granted final approval to LUMRYZ, an extended-release formulation of sodium oxybate indicated to be taken once at bedtime for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. With final approval, LUMRYZ becomes the first and only FDA approved once-at-bedtime oxybate for people living with narcolepsy. LUMRYZ was additionally granted Orphan Drug Exclusivity by the FDA. The FDA’s final approval of LUMRYZ was based on 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 for all three doses evaluated, 6, 7.5 and 9 grams. With this approval, the FDA has also found LUMRYZ to be clinically superior to currently marketed twice-nightly oxybate products and granted LUMRYZ seven years of Orphan Drug Exclusivity. 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. The FDA’s Orphan Drug program is designed to support the development of drugs that treat a condition affecting less than 200,000 U.S. patients. The seven-year market exclusivity for LUMRYZ began on the date of FDA approval, May 1, 2023.