Avadel Pharmaceuticals requests final FDA approval for LUMRYZ

Avadel Pharmaceuticals (AVDL) announced that it has submitted an amendment to the U.S. Food and Drug Administration, FDA, requesting final approval for LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness, EDS, in adults with narcolepsy. This submission follows a unanimous 3-0 panel decision by the United States Court of Appeals for the Federal Court on February 24, affirming the previous ruling from the United States District Court for the District of Delaware, ordering Jazz Pharmaceuticals (JAZZ) to delist its U.S. Patent No. 8,731,963 from FDA’s Orange Book. Jazz submitted its request to delist the REMS Patent to FDA on February 28. Based on extensive patient and physician research, Avadel estimates the total potential patient population for once-at-bedtime LUMRYZ could be greater than 30,000, and expects LUMRYZ, if approved, to be the treatment of choice for patients suffering from narcolepsy-related EDS or cataplexy. The current twice-nightly oxybate market for narcolepsy in the U.S. is estimated at $1.8 billion comprised of approximately 16,000 patients. In addition, Avadel estimates that in the last three years, 10,000 – 15,000 patients have discontinued their twice-nightly oxybate use, many due to complications associated with middle-of-the-night dosing. Based on the estimated total potential patient population, the market opportunity could be in excess of $3.0 billion annually.