(RTTNews) - Alkermes plc (ALKS), a biopharmaceutical company, on Tuesday reported that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Alixorexton for the treatment of narcolepsy type 1 or NTI.
The designation was based on phase 1 and phase 2 clinical data, including positive results from the phase 2 Vibrance-1 study.
Narcolepsy type 1 is marked by persistent daytime sleepiness, stemming from a deficiency in orexin, a neuropeptide generated in the hypothalamus that serves as a key regulator of wakefulness.
Alixorexton, an investigational, oral, selective orexin 2 receptor (OX2R) agonist, is in development for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH).
The Vibrance-1 study was a phase 2, randomized, double-blind, placebo-controlled, dose-range-finding study with 92 participants that evaluated the safety and efficacy of the investigational drug alixorexton in adults with narcolepsy type 1.
In the Vibrance-1 phase 2 study, Alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful, and dose-dependent improvements from baseline compared with placebo on the Maintenance of Wakefulness Test in patients with NT1.
Alixorexton was reported to be generally well-tolerated at all doses tested.
Alkermes look forward to working closely with the FDA as they plan to advance Alixorexton into a phase 3 program in patients with narcolepsy type 1 and type 2 in the first quarter of 2026.
For the third quarter of 2025, Alkermes reported $394.2 million total revenue driven by a 16% year-over-year growth in net sales of its proprietary products, including VIVITROL, ARISTADA and LYBALVI.
ALKS closed Monday's trade at $28, down 0.92%; In the pre-market, ALKS is is trading 1.96% up at $28.55.
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