Extended-Release Narcolepsy Drug Shows Promise in Once-a-Night Dose

ON-SXB is a narcolepsy drug that should be taken once at bedtime and has effectively and safely improved symptoms compared with an alternative that is taken once at bedtime and once in the middle of the night, investigators at Stanford Medicine found in a recent study.

“Sodium oxybate has largely become a first-line treatment for patients with narcolepsy,” Clete Kushida, MD, PhD, a professor of psychiatry and behavioral sciences at Stanford University, said in a statement.

“Clinicians can be confident that a single dose of sodium oxybate has demonstrated efficacy for both objective and subjective symptoms of narcolepsy.”

Sodium oxybate is intended to be taken twice at night to treat multiple symptoms of narcolepsy, including excessive daytime sleepiness and sudden muscle weakness while awake.

ON-SXB is an extended-release version of sodium oxybate that is taken once at bedtime. In the phase 3 study, the drug decreased narcoleptic symptoms more effectively than the placebo but also increased the overall condition of individuals. The adverse effects, the results show, are like those of the twice-a-night version of sodium oxybate.

Individuals who took the 3 highest doses of ON-SXB saw decreased daytime sleepiness, muscle weakness, and self-rated sleepiness in everyday situations.

Investigators said that 72% of the individuals’ conditions, when taking the highest dose, were considered much or very much improved, compared with the 31.6% in the placebo group.

“If approved, ON-SXB may be a major advance for patients experiencing the burdensome symptoms of narcolepsy and for physicians who manage their patients with this chronic, incapacitating sleep disorder,” Kushida said.

Reference

Stanford researchers shows once-nightly narcolepsy drug is safe, effective. Stanford Medicine. News release. September 8, 2021. Accessed September 27, 2021. https://med.stanford.edu/news/all-news/2021/09/narcolepsy-drug.html