Press Releases
View printer-friendly version << Back
Avadel Presents New Data Supporting Clinical Benefit with Once-at-Bedtime FT218 and Preference for Once-Nightly Dosing in Patients with Narcolepsy at CHEST 2021
- 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 -
“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
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
Avadel also presented encore posters featuring post hoc analyses from the REST-ON trial at the annual meeting of the
About FT218
FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
In
In
About
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, our expectations of the therapeutic benefits of FT218, the timing of the FDA’s review of our NDA for FT218, the sufficiency of data supporting our NDA for FT218, the commercial launch of FT218 (if approved), and the market acceptance of FT218 (if approved). In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).
Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, our business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in our forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. We do not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Contacts:
Investor Contact:
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
(212) 698-8687
Media Contact:
Real Chemistry
ngoelz@realchemistry.com
(408) 568-4292
Source: Avadel Pharmaceuticals plc