STAT+: Alkermes’ orexin agonist shows potential to treat ADHD in early-stage trial — SkimNews
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- Alkermes reported that its orexin agonist ALKS 7290 was well tolerated and showed a signal of efficacy in a randomized Phase 1 study in adults with ADHD.
- ALKS 7290 is the first drug in the orexin agonist class — previously limited to rare sleep disorders — to demonstrate potential benefit for ADHD, according to the company.
- Trial participants started with a median baseline score of 39 on the Adult ADHD Investigator Symptom Rating Scale, indicating moderate to severe symptoms.
- After two weeks on a high 50mg dose, patients experienced a 19-point reduction on the rating scale, dropping their symptoms into the mild range.
- Alkermes announced the Phase 1 data on Monday, framing the results as proof-of-concept that orexin agonism extends beyond sleep disorders into neuropsychiatric conditions.
Why it matters: Orexin agonists have so far been confined to rare sleep disorders, so Alkermes just opened a far larger ADHD market with a non-stimulant mechanism — a notable angle given stimulant shortages and side-effect concerns in the space. The 19-point drop on a validated rating scale after only two weeks is a strong Phase 1 signal, but the small cohort and early stage mean larger Phase 2 and 3 trials are needed to confirm whether the effect holds.
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