Alkermes plc said its experimental narcolepsy treatment alixorexton met key Phase 2 trial goals, demonstrating statistically significant improvements in excessive daytime sleepiness versus placebo.
The randomized, placebo-controlled Vibrance-1 study enrolled 92 adults with narcolepsy type 1, testing once-daily doses of 4 mg, 6 mg, or 8 mg of alixorexton over six weeks. All dosage groups achieved mean sleep latency values within the normative range of at least 20 minutes in the Maintenance of Wakefulness Test and Epworth Sleepiness Scale scores of 10 or lower at week six.
The 6 mg cohort also showed a reduction in weekly cataplexy rates compared to placebo. The drug was generally well tolerated, with most treatment-emergent adverse events mild to moderate and no serious events reported.
Alkermes holds U.S. Food and Drug Administration breakthrough therapy designation for narcolepsy type 1 and orphan drug designation for idiopathic hypersomnia. The company has initiated the Brilliance Studies, a global Phase 3 program evaluating single and split-dose regimens of alixorexton in adults with narcolepsy type 1 and type 2.
Results from the trial were published in The Lancet Neurology. Alkermes, headquartered in Ireland with facilities in Massachusetts and Ohio, develops treatments for alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder, and narcolepsy.
