A new post-hoc analyses for the sodium oxybate FT218 found that the therapy improved daytime sleepiness, sleep quality, and refreshing nature of sleep in patients with narcolepsy.
How has sleep medicine changed in recent years, and what does the future hold? These are questions that are being asked this week at the World Sleep 2022 congress in Rome, Italy, and new data presented at the conference by Avadel Pharmaceuticals could provide a answers for patients struggling from narcolepsy.
A new post-hoc analyses for the sodium oxybate FT218 found that the therapy improved daytime sleepiness, sleep quality, and refreshing nature of sleep in patients with narcolepsy. It’s safety and efficacy was well established in the ongoing RESTORE study and the REST-ON trial, with participants receiving therapy for more than 18 months in the former.
In an interview with HCPLive, Michael J. Thorpy, MD, director of the Sleep-Wake Disorders Center at Montefiore and professor of neurology at Albert Einstein College of Medicine, spoke of the implications of FT218 data in the realm of narcolepsy research.
“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. “So, patients don't have to wake up to take a second dose.”
A new drug application for FT218 is currently under review by the FDA, which is supported by positive efficacy and safety data.
Though Thorpy did not know when the therapy would be approved, he was already willing to look towards the future regarding FT218 treatment for pediatric populations with narcolepsy.
“One of the things about narcolepsy is at the median age of onset of narcolepsy of 16 years, so that means that half the population actually develops before the age of 16,” Thorpy said. “So I'm hoping that the company would look at it in children, because oxybate when 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 even children.”
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