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 in the placebo group (least squares mean difference [LSMD], 6.13; 95% CI, 3.52-8.75).
In addition, 72.0% of patients in the SXB 9g group achieved a much/very much improved rating on the Clinical Global Impression-Improvement scale compared with 31.6% in the placebo group (odds ratio, 5.56; 95% CI, 2.76-11.23). Likewise, change in weekly cataplexy attacks was -11.5 versus -4.9 for the 9g and placebo groups, respectively (LSMD, -6.65; 95% CI, -9.32 to -3.98).
Authors noted that ON-SXB was being reviewed by the FDA. “If approved,” they closed, “ON-SXB may represent a major advance for patients experiencing the burdensome symptoms of narcolepsy and for physicians who manage their patients with this chronic, debilitating sleep disorder.”
Related: Examining REM Period Temporal Distribution in Narcolepsy