FT218 Improves Sleep Quality, Daytime Sleepiness in Narcolepsy Patients

Late last week, Avadel Pharmaceuticals announced new data for a once-at-bedtime investigational narcolepsy therapy called FT218.

The data, which will be presented at the World Sleep 2022 conference in Rome, demonstrated that FT218 provided improvement in subjective measures of daytime sleepiness, sleep quality, and refreshing nature of sleep in the phase 3 REST-ON clinical trial.

Additional, the companies presentation of an interim safety analysis from the ongoing RESTORE study indicated that FT218 was generally well tolerated with participants receiving therapy for over 18 months.

“FT218 is a new formulation that allows for the drug to be given with a single dose at the beginning of the night,” said Michael Thorpy, MD, MB, Director of the Sleep-Wake Disorder Center at the Montefiore Medical Center and professor of neurology at Albert Einstein College of Medicine. “So, patients don't have to wake up to take a second dose.”

Though traditional oxybate has been available for patients with narcolepsy, it was intended to be taken twice a night. This would prove to be inconvenient for many patients, as they would often fall asleep before they could admninister the second dose.

With FT218, patients with narcolepsy – approximately 130,000-200,000 of whom are in the US alone- patients can manage their symptoms more easily with a single-dose option and continue treatment for longer periods of time.

With positive efficacy, safety, and adverse event data, Thorpy hopes that future studies of FT218 will focus on younger populations affected by narcolepsy.

“One of the things about narcolepsy is at the median age of onset of narcolepsy of 16 years,” Thorpy said. “So, I'm hoping that the company would look at it and children, because oxybate in where it's taken twice at night is available for children from 7 years and up. So I'm hoping that this company will consider doing a pediatric study so that we can get everyone treated with (FT218), even children.”

A new drug application for FT218 is currently under review by the FDA.

To hear more from Dr. Thorpy on the REST-ON and RESTORE studies, watch the full interview above.