Sponsor Name: Flamel Ireland Ltd d/b/a Avadel Ireland
Regulatory Agency Identifier Numbers: IND: 168810
Rationale: The efficacy of oxybates to treat IH in adult patients was established in a double-blind randomized withdrawal trial (Dauvilliers 2022; XYWAV® package insert). Considering that Xywav and FT218 have the same active moiety, there is considerable evidence that FT218 is a viable treatment option for IH. Particularly, the worsening in Epworth Sleepiness Scale (ESS) score for patients on placebo compared to Xywav following withdrawal, after being on an effective stable dose, demonstrated that oxybates are effective at treating EDS. Taken with the secondary endpoints of Patient Global Impression of change (PGI-C) and Idiopathic Hypersomnia Severity Scale (IHSS) total scores, both of which significantly worsened after placebo withdrawal, FT218 is expected to effectively treat IH.