Once-at-Bedtime Sodium Oxybate Therapy for Narcolepsy Preferred Among Patients and Clinicians 

Sodium oxybate therapy (FT218; Avadel Pharmaceuticals, Chesterfield, MO) with once-nightly dosing was preferred in a discrete choice experiment over twice-nightly dosing. Clinical trial results also show that this formulation of sodium oxybate improved daytime sleepiness, sleep quality, and refreshing nature of sleep for individuals with narcolepsy. 
 
“We know that untreated narcolepsy can have a devastating effect on patients’ quality of life and ability to function and that additional treatment options would benefit patients and clinicians. Results from the discrete choice experiment identified that the overall driver of treatment choice for oxybate therapy is once-nightly dosing,” said Anne Marie Morse, DO, director of Child Neurology and Pediatric Sleep Medicine at Geisinger Medical Center at Janet Weis Children’s Hospital. “Taken together with the robust clinical data already published, along with new post-hoc analyses from the pivotal trial and interim long-term data from the ongoing open-label study to be presented at World Sleep, FT218 shows great potential for patient care.”
 
In the discrete-choice study, once-nightly dosing was preferred over the possibility of improvements in quality of life and reduction of individual’s anxiety and stress. This formulation of sodium oxybate also demonstrated improvements as early as 1 week with the 4.5-g starting dose, with increased improvement at the second week soon after starting the 6-g dose compared with placebo.

“In our first look at data from the interim analysis of the ongoing RESTORE study (NCT04451668), we have affirmed that the tolerability of FT218 is in line with the well-established profile of sodium oxybate. We’re also pleased to share new results from our post-hoc analyses of the REST-ON trial (NCT02720744) that demonstrated clinically meaningful improvements with FT218 versus placebo in both subjective and objective measurements of narcolepsy symptoms, including EDS and disrupted nighttime sleep, with a dosing regimen preferred by patients and clinicians alike, consistent with our previous observations,” said Douglas Williamson, MD, chief medical officer of Avadel. “At Avadel, we believe in listening to patients to develop solutions that will have a meaningful impact on their symptoms. Our goal is to do just that for people living with narcolepsy, and we are working to bring FT218 to patients as a once-at-bedtime treatment option as quickly as possible.”

The sodium oxybate therapy is an investigational formulation designed to be taken once at bedtime for excessive daytime sleepiness (EDS) treatment or cataplexy in adults with narcolepsy.