Avadel Pharmaceuticals is still waiting on an answer from the FDA on whether its once-nightly narcolepsy drug Lumryz will be approved to include the pediatric population after the agency missed the Sep. 7 PDUFA date.
In a Sept. 12 securities filing, Avadel wrote that it has been in “recent communication” with the FDA and that the supplemental NDA “remains under review.”
“Avadel is committed to working closely with the FDA for the remainder of the review process,” the securities filing added.
A representative for Avadel confirmed with Endpoints News that the delay is not due to a CRL.
Avadel filed for approval with the FDA in November following Lumryz’s approval in the adult population in 2023. Lumryz generated about $28 million in sales last year, and Leerink Partners analysts estimated in August that Lumryz could grab more than 20% of the market share in narcolepsy.
Jefferies analysts wrote in a Thursday note that potential FDA approval of Lumryz in pediatric narcolepsy is a $100 million opportunity, and the 11% reduction in the company’s price action in the past five days is due to three issues, including “investor confusion” over the delayed PDUFA decision.
Avadel won a multi-year court battle with Jazz in 2023 over the latter’s patent for Xyrem, which is dosed twice a night. But it did lose in an IP infringement case against Jazz where the judge recently banned Lumryz in idiopathic hypersomnia, the Jefferies analysts noted “but [Avadel] has already appealed and IH is all valuation upside anyway.”