Avadel’s narcolepsy Phase III trial shows positive results
pharmafile | June 16, 2021 | News story | Research and Development |
Avadel’s Phase III trial for FT218 in patients with narcolepsy has shown positive results.
The data from the trial demonstrated that FT218 led to an improvement in excessive daytime sleepiness for both narcolepsy subtypes, as well as decreases in weight and body mass index.
FT218, an investigational, once-nightly formulation of sodium oxybate for treating excessive daytime sleepiness and cataplexy in adults with narcolepsy, offers a much simpler dosing regimen than treatments that are currently available.
The drug is currently under review by the FDA.
FT218 demonstrated statistically significant improvement in excessive daytime sleepiness (EDS) at all evaluated doses in patients with narcolepsy subtypes 1 (NT1, with cataplexy) and 2 (NT2, without cataplexy), with greater improvement in measures of EDS, including mean sleep latency on maintenance of wakefulness test (MWT), and clinical global impression-improvement (CGI-I) in overall condition, compared to placebo.
Asim Roy, Trial Investigator and Medical Director of the Ohio Sleep Medicine Institute, said: “For the past 20 years, the standard of care for narcolepsy has been a twice-nightly medication, a challenging dosing regimen that disrupts night time sleep.
“The new data from the REST-ON trial demonstrate that the once-nightly formulation of sodium oxybate taken at bedtime was effective in addressing the symptoms of narcolepsy without requiring the patient to wake up in the middle of the night.
“The new data analyses showing that FT218 improved excessive daytime sleepiness in patients with narcolepsy, both with and without cataplexy, regardless of stimulant use, are important for this patient population.
“Moreover, the data demonstrating a reduction in weight is an added benefit for narcolepsy patients, who tend to be overweight. I am encouraged by these and other data and believe FT218, if FDA approved, will be an important once-nightly treatment option for people who struggle with managing narcolepsy.”
Jennifer Gudeman, PharmD, Vice President of Medical and Clinical Affairs at Avadel, said: “Avadel is focused on providing a meaningful solution for people with narcolepsy and we are pleased to share further evidence of the clinical benefit of FT218, taken once at bedtime.
“We leveraged our unique scientific capabilities to develop a proprietary formulation of sodium oxybate to address the limitations of currently available treatments that require twice-nightly dosing.
“We believe these new analyses, along with previously presented REST-ON positive Phase III data, strengthen the body of evidence demonstrating that FT218, if approved, has the potential to be a transformative treatment for people living with narcolepsy.”
Narcolepsy is a disabling disease characterised by excessive daytime sleepiness, cataplexy, fragmented sleep patterns, hallucinations, and sleep paralysis.
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