Once-Nightly Sodium Oxybate Formulation for Narcolepsy

Credit: Original article published here.In the phase 3 REST-ON study, researchers evaluated the safety and efficacy of FT218, a novel once-nightly sodium oxybate (ON-SXB) formulation, in improving sleep quality in patients with narcolepsy. Authors noted that FT218 uses an investigational, extended-release formulation to allow for once-daily SXB dosing rather than twice-nightly. According to the study’s lead author, Clete A Kushida, treatment with FT218 significantly improved participants’ narcolepsy symptoms compared with placebo, and had a safety profile consistent with existing two-nighttime dose SXB treatments. The findings were published in Sleep. Once-Nightly Dosing WIth Novel Sodium Oxybate Formulation A total of 212 patients received at least 1 study dose, 107 in the ON-SXB group and 105 in the placebo group. ON-SXB was assessed at doses of 6, 7.5, and 9g. The 3 primary end points were change from baseline in mean sleep latency on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement rating, and weekly cataplexy attacks. Reportedly, all 3 doses of ON-SXB yielded clinically meaningful improvements compared with placebo across the 3 primary end points and Epworth Sleepiness Scale values (P<.001). Authors specified that the ON-SXB 9g group had a mean increase in sleep latency of 10.8 minutes versus 4.7 minutes

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