Avadel Pharmaceuticals plc recently provided a corporate update and announced its financial results for the third quarter ended September 30, 2021.
“The need for patients living with the chronic, debilitating condition of narcolepsy to have a single bedtime dose of sodium oxybate is clear. We are confident in the strength of our data and our regulatory filing strategy for FT218, as the FDA [Food and Drug Administration] continues their review of our NDA [new drug application]. Importantly, there are no outstanding requests from the FDA at this time, and questions previously received have been addressed. We remain committed to patients and sleep specialists, demonstrated by the significant advances we made during 2021 to support a successful launch of FT218, if approved,” says Greg Divis, CEO of Avadel, in a release. “This quarter, we published the primary REST-ON results in the SLEEP journal and continued to externalize the robust dataset supporting the potential of FT218 in various scientific congresses. Additionally, payor discussions continue to advance, and we are growing our commercial team, all with the vision of disrupting the narcolepsy market and fulfilling our promise to the narcolepsy community by bring FT218 to patients.”
Third Quarter & Recent Company Highlights
- In October 2021, the FDA informed the company that the review of its new drug application (NDA) for FT218 was ongoing beyond its previously assigned target action date.
- Continued preparations and launch readiness activities for the potential commercialization of FT218 as the first and only once-at-bedtime option for managing excessive daytime sleepiness (EDS) and cataplexy in narcolepsy.
- Multiple presentations and publications in peer-reviewed forums of data from the pivotal Phase 3 REST-ON study of FT218 throughout the quarter, including: published the previously announced primary results in SLEEP; presented new data at the American College of Chest Physicians annual meeting supporting the clinical benefit of once-at-bedtime FT218 and patient preference for once-nightly dosing (new post-hoc responder analyses demonstrated FT218 treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes and statistically significant improvements compared to placebo on mean sleep latency; discrete choice experiment demonstrated that the strongest driver of patient preference for sodium oxybate was dosing frequency with once-nightly dosing preferred); presented encore posters featuring post hoc analyses from the REST-ON study at the meeting of the American Neurological Association.
- Progressed the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly oxybates and patient preference. Avadel plans to present data from RESTORE study on patient preference to once-nightly or twice-nightly dosing regimens, as well as nocturnal experiences when using twice-nightly sodium, at future medical congresses.