Avadel delay hands Jazz another narcolepsy boost

A delay to the FDA’s decision on Avadel’s narcolepsy project, FT218, allows Jazz investors a second bout of schadenfreude in as many weeks. The once-a-night pill could become a big competitor to Jazz’s twice-a-night Xyrem/Xyway franchise; the news follows the exit of another potential rival, Takeda’s TAK-994, recently abandoned on safety concerns. When the FDA’s verdict on FT218, which had a Pdufa date of October 15, might emerge is unclear. Avadel insists the regulator made no new information requests, saying only that action was unlikely in October. A short delay due to a lack of resources at the agency would be the best case scenario. However, the FDA could be mulling more serious issues, Stifel analysts mooted: firstly that Avadel might need to go down the generic filing route – Xyrem/Xyway and FT218 contain the same active ingredient – a scenario that would lead to a 30-month stay to approval. Or perhaps the agency is considering whether FT218 really deserves orphan drug exclusivity, which is largely based on its dosage advantage. A 15% drop in Avadel’s stock this morning suggests investors are cautiously optimistic that the delay will be short. The outlook for the narcolespy market, below, shows what is in play.