Biopharmaceutical company Alkermes plc (Nasdaq:ALKS) announced on Friday that it has initiated a phase 2 clinical study evaluating ALKS 7290 as an adjunctive treatment for adults with major depressive disorder (MDD), expanding the development programme for its investigational orexin 2 receptor (OX2R) agonist.
The randomised, double-blind, placebo-controlled study will assess the safety and efficacy of ALKS 7290 alongside standard antidepressant therapy in adults with and without excessive daytime sleepiness. Approximately 180 participants are expected to enrol and will receive either ALKS 7290 or placebo alongside antidepressants over six weeks.
The primary objective is to evaluate the drug's safety and tolerability, while secondary objectives include assessing changes in depression symptom severity using the Montgomery–Åsberg Depression Rating Scale and Clinical Global Impressions-Severity Scale.
ALKS 7290 is also under development for the treatment of attention-deficit hyperactivity disorder (ADHD).
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