Avadel Pharmaceuticals has taken a step toward challenging Jazz Pharmaceuticals for the narcolepsy market. The FDA granted tentative approval to the company’s extended-release rival to Xyrem, leaving a patent as the last barrier between it and the market.
Today, narcolepsy patients who take sodium oxybate to treat excessive daytime sleepiness and sudden muscle weakness need to take two doses a night. The short half-life and immediate-release formulation means a second dose is needed around three hours after the first. Avadel wants to enable once-nightly dosing by bringing an extended-release sodium oxybate formulation to market.
The FDA gave tentative approval to the candidate, Lumryz, last week, indicating that Avadel had met all the quality, safety and efficacy standards needed to bring the drug to market in the U.S. Avadel aims to launch Lumryz by June 2023, but the timing of the final approval depends on a patent owned by Jazz.
Last month, Avadel filed a motion to delist the Jazz patent, which describes a sensitive drug distribution system and method, from the FDA’s Orange Book. If the court requires Jazz to delist the patent, Avadel could win final approval before June 2023. Avadel is also preparing for a claim construction hearing that is set to take place at the end of next month.
Lumryz poses a threat to Jazz’s Xyrem, the twice-nightly incumbent in the narcolepsy market. Based on its less burdensome dosing schedule, Avadel expects Lumryz to become the treatment of choice once it comes to market.
Jazz is fighting back in the courts, launching multiple legal actions last year and following up around the same time as the FDA granted tentative approval with a lawsuit that alleges the infringement of a patent.