Alkermes Advances Narcolepsy Therapy with Promising Phase 2 Trial Results for Alixorexton
Alkermes’ drug alixorexton (previously ALKS 2680) demonstrated positive, statistically significant results in a Phase 2 trial for narcolepsy type 1, improving wakefulness and reducing excessive daytime sleepiness compared to placebo.
All three doses tested achieved the primary endpoint by enabling patients to reach 'normative wakefulness', meaning they took more than 20 minutes to fall asleep in a controlled test environment.
The drug was generally well tolerated with no serious treatment-emergent adverse events or safety signals observed in vital signs, liver, kidney, or eye exams.
The trial enrolled 92 adults with narcolepsy type 1 and showed that the middle dose also significantly reduced the frequency of cataplexy, sudden muscle weakness associated with the condition.
Alkermes plans to advance alixorexton into late-stage (Phase 3) testing following these encouraging mid-stage results.
Additional ongoing studies are evaluating alixorexton in narcolepsy type 2 and idiopathic hypersomnia patients.
More detailed data is expected to be presented at a medical meeting in Singapore in September 2025.