FT218 shows promise for narcolepsy
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A 13-week phase 3 clinical trial showed sustained efficacy and safety among users of the sodium oxybate therapy FT218 for the treatment of excessive daytime sleepiness and cataplexy narcolepsy, a press release from its manufacturer stated.
Recipients of FT218 (Avadel Pharmaceuticals), compared with those who took placebo, showed “statistically significant” and “clinically meaningful” improvement on Maintenance of Wakefulness and Clinical Global Impression-Improvement tests and mean number of weekly cataplexy attacks (P < .001 for all). These results were present in all three doses (6 g, 7.5 g and 9 g), according to the press release.
Overall, the 9 g dose of once-nightly FT218 was generally well tolerated, according to Avadel Pharmaceuticals. The most commonly known adverse events among the trial’s 212 participants were enuresis (9%), vomiting (5.2%), dizziness (5.2%), somnolence (3.9%), decreased appetite (2.6%), nausea (1.3%) and tremor (1.3%). The discontinuation rate due to adverse reactions at the 9 g dose of once-nightly FT218 was 3.9%.
“Once-nightly FT218 delivered a clinically meaningful response within 3 weeks of treatment initiation, which was sustained through each treatment period,” Jordan Dubow, MD, chief medical officer of Avadel, said in the press release. “Commonly known sodium oxybate adverse reactions occurred at low rates at the highest dose level. We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care.”
Avadel Pharmaceutics plans to submit a new drug application for the approval of FT218 to the FDA, according to the press release.
Disclosure: Dubow is chief medical officer for Avadel Pharmaceuticals.
Perspective
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Camilo A. Ruiz, DO, FACOI, FAASM
With other prescription drugs for narcolepsy, patients often have to take a dose when they go to bed and then wake up 2 to 3 hours later to take a second dose. Patients with narcolepsy have poor sleep quality, and so although the other prescription drugs are helpful in some ways, such multiple dosing schedules take a toll on the patient’s sleep quality.
FT218 is an extended-release formulation that eliminates waking up for the second dose and still provides the same effect as the other prescription drugs for narcolepsy. This is fantastic news. FT218, if approved by the FDA, would be an obvious next step for patients with narcolepsy to try.
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