Alkermes plc  announced the initiation of a phase 2 study evaluating the safety and efficacy of ALKS 7290 as an adjunctive therapy to antidepressants in adult participants with major depressive disorder (MDD). ALKS 7290 is the company’s investigational orexin 2 receptor (OX2R) agonist in development for the treatment of attention-deficit hyperactivity disorder (ADHD) and for the adjunctive treatment of MDD.

“Orexin biology represents a compelling area of scientific exploration in neuropsychiatry, given its central role in regulating wakefulness and its broad connections to neural circuits relevant to attention, cognition and mood. Through this phase 2, proof-of-concept study, we aim to assess whether activation of the orexin system may offer a novel approach to addressing symptoms of major depressive disorder,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. “The initiation of this study marks another important milestone in the rapid advancement of our portfolio of orexin 2 receptor agonists and reflects our commitment to maintaining a leadership position in the development of orexin-based therapies across multiple neuropsychiatric indications.”

The phase 2, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of ALKS 7290 as an adjunctive treatment to standard antidepressants in adults with MDD, including those with and without excessive daytime sleepiness. Participants will be randomized to receive ALKS 7290 or placebo, along with antidepressant therapy (ADT), for six weeks. The study’s primary objective is to evaluate the safety and tolerability of ALKS 7290. The secondary objective is to evaluate whether participants taking ALKS 7290 plus ADT experience an improvement in severity of MDD symptoms compared to participants taking placebo plus ADT, as measured by a change from baseline on the Montgomery–Åsberg Depression Rating Scale (MADRS) and on the Clinical Global Impressions-Severity Scale (CGI-S) at week six.