The director of the Sleep-Wake Disorders Center at Montefiore Medical Center discussed the formulaic background of FT218 and why it’s so effective in treating sleep disorders.
"It has that advantage of needing to be given only once a night so that patients don’t need to wake up during the middle of the night to get a second dose.”
At the 2021 SLEEP Virtual Annual Meeting, June 10-13, multiple abstracts from the phase 3 REST-ON study (NCT02720744) showed that Avadel’s investigational agent FT218 reduced sleep latency across narcolepsy subtypes and produced greater decreases in weight and body mass index than placebo. FT218, a once-nightly sodium oxybate formulation, also improved excessive daytime sleepiness (EDS) in those regardless of stimulant use.
Data from the study was the basis for the company’s recent new drug application, which the FDA accepted and has thus assigned a Prescription Drug User Fee Act action date of October 15, 2021. Michael J. Thorpy, MD, ChB, director, Sleep-Wake Disorders Center, Montefiore Medical Center, said that sodium oxybate has been the standard for treating patients with sleep disorders since its original approval.
In an interview with NeurologyLive, Thorpy detailed why FT218 has potential to be a useful treatment within a growing landscape of narcolepsy care, and why its mechanism of action can lend itself to helping to treat other aspects of the sleep disorder, such as disturbed nocturnal sleep.
For more coverage of SLEEP 2021, click here.