Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."
The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."
Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."
The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."
The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.
Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.
Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).
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