Jazz Advances Narcolepsy Drug To Phase 3

Jazz Pharmaceuticals reported positive Phase IIB results for its narcolepsy drug JZP-110 for the treatment of excessive daytime sleepiness (EDS) in adults with narcolepsy. The company announced that based on the JZP-110’s consistent alerting effect seen in trials, it is moving the drug into Phase III clinical development.

Narcolepsy is a sleep disorder in which the brain is unable to regulate sleep-wake cycles normally. The disorder affects an estimated 1 in 2,000 people in the U.S. alone. Excessive daytime sleepiness, characterized by unexpected lapses into sleep or drowsiness, is the primary symptom of narcolepsy.

JZP-110 is an investigational compound for the treatment of EDS in adults with narcolepsy and adults with OSA. The company acquired the rights to JZP-110 from Aerial BioPharma early this year.

The multi center, double-blind, parallel-group, placebo-controlled Phase IIB study showed that patients with an ICSD-2 diagnosis of narcolepsy who were treated with JZP-110 experienced statistically significant improvements in objective and subjective symptoms of EDS. Co-primary efficacy endpoints were change from baseline of average sleep onset latency (SOL) on the Maintenance of Wakefulness Test (MWT). The trial’s secondary endpoint was a change from baseline at weeks 4 and 12 on the Epworth Sleepiness Scale (ESS), a subjective measure of sleepiness completed by patients. The trial achieved both its primary and secondary endpoint compared to those who took placebo.

“These results are highly consistent with the robust alerting effects seen in the Phase 2a clinical study and add to the body of evidence supporting the potential clinical benefit of JZP-110 for patients suffering from EDS. We believe this is an important development program for the sleep community because many patients with EDS experience an inadequate response to, or difficulty tolerating, their currently prescribed alerting medications,” said Jed Black, vice president, sleep medicine, Jazz Pharmaceuticals, and consulting associate professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine.

The trial data were presented during the 28th Annual Meeting of the Associated Professional Sleep Societies (APSS) ‘SLEEP 2014’ held in Minneapolis.