Benzinga | Oct 19, 2021 08:22AM EDT

Avadel Pharma Highlights New Data On Once-At-Bedtime FT218, Preference For Once-Nightly Dosing In Patients With Narcolepsy At American College of Chest Physicians Meeting

- Post-hoc responder analyses demonstrated a significantly greater proportion of patients receiving FT218 experienced reductions in weekly cataplexy attacks and improvement in mean sleep latency compared to placebo -

- Discrete choice experiment demonstrated that the strongest relative driver of overall product choice was number of doses with once-nightly preferred versus twice-nightly dosing regimen between sodium oxybate -

DUBLIN, Oct. 19, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL), a company focused on transforming medicines to transform lives, today announced new data from the completed pivotal Phase 3 REST-ON clinical trial of FT218, also known as ON-SXB. The post-hoc data are being presented in as two separate posters at the American College of Chest Physicians (CHEST) annual meeting, taking place virtually October 17 -- 20, 2021, along with the results of a discrete choice experiment (DCE) to understand patient preference. FT218 is the Company's lead drug candidate, an investigational formulation of sodium oxybate designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy. FT218 is currently under review at the U.S. Food and Drug Administration.

"The new post-hoc responder analyses demonstrating that ON-SXB improved EDS provide further confidence in ON-SXB for people with narcolepsy. We believe this is critical for a patient population whose quality of life is severely impacted by EDS," said John Winkelman, M.D., Ph.D., presenting author, professor of Psychiatry at Harvard Medical School and chief of the Sleep Disorders Clinical Research Program in the Department of Psychiatry at Massachusetts General Hospital. "These ON-SXB data represent a compelling way to set expectations for patients receiving therapy. I believe that ON-SXB, a once-nightly treatment option that has demonstrated clinical benefit in a randomized controlled trial, is a meaningful advance in treatment and, if approved, will be a welcome option for patients and physicians alike."

Highlights from the poster presentations are outlined below.

Sleep Latency Response with FT218, a Once-Nightly Sodium Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial

* ON-SXB (FT218) treatment was associated with statistically significant improvements compared to placebo on mean sleep latency, as shown by the results of the Maintenance of Wakefulness Test, a measure of EDS, in the pivotal Phase 3 REST-ON clinical trial: A significantly greater proportion of participants who received ON-SXB compared to placebo experienced increased mean sleep latency change from baseline ranging from ?5 minutes to 30 minutes Improvement was evident as early as week 3 at the 6-g dose and increased with the 7.5-g dose at week 8 and the 9-g dose at week 13 The most common adverse drug reactions (?5%) with ON-SXB 9 g were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)

Cataplexy Response with FT218, a Once-Nightly Sodium Oxybate (ON-SXB): Post-Hoc Responder Analyses from the Phase 3 REST-ON Clinical Trial

* ON-SXB (FT218) treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes, as shown by the results of the pivotal Phase 3 REST-ON clinical trial: A significantly greater proportion of participants treated with ON-SXB compared to placebo experienced 25%, 50% and 75% reductions in the number of weekly cataplexy episodes with once-at-bedtime doses of 6, 7.5, and 9 g Of participants taking the two highest doses (7.5 and 9 g) of ON-SXB, approximately 10% had complete elimination of their cataplexy, while approximately half had a 50% reduction and one-third had a 75% reduction in their weekly cataplexy episodes The most common adverse drug reactions (?5%) with ON-SXB 9 g were enuresis (9.1%), dizziness (5.2%), and vomiting (5.2%)

The Utility of Discrete Choice Experiment in Evaluating Treatment Preferences Among Patients with Narcolepsy

* A discrete choice experiment evaluated drivers of patient preference for sodium oxybate and demonstrated that dosing frequency was the single most important attribute of a narcolepsy treatment, with once-nightly dosing significantly more preferred than twice-nightly dosing (P<0.001).

* The number of nightly doses was also the most important driver observed of "taking the medication exactly as directed" and "reduced anxiety/stress", with once-nightly dosing preferred over twice-nightly dosing.

"Avadel is focused on transforming medicines to transform lives, and FT218, if approved, has the potential to be an innovative solution for patients living with the chronic condition of narcolepsy," said Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel. "FT218 has demonstrated meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients. We believe in listening to patients to deliver solutions that improve their symptoms and look forward to our ongoing partnership with the narcolepsy community as we strive to make FT218 available to patients and prescribers."

Avadel also presented encore posters featuring post hoc analyses from the REST-ON trial at the annual meeting of the American Neurological Association, taking place virtually October 17 -- 19, 2021, which affirmed the clinical benefit of FT218 on EDS, regardless of narcolepsy subtype (NT1, with cataplexy and NT2, without cataplexy) and with or without concomitant stimulant use, while also demonstrating a modest reduction in weight and body mass index over the 13-week trial.