Otsuka and Sunovion Initiate Clinical Development of Ulotaront for the Adjunctive Treatment of Major Depressive Disorder
First Trial to Study a Trace Amine-Associated Receptor 1 (TAAR1) Agonist in Major Depressive Disorder (MDD)
Excerpt from the Press Release:
PRINCETON, N.J. & MARLBOROUGH, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the first patient has been enrolled in a Phase 2/3 clinical study to evaluate ulotaront (SEP-363856), a trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, as an adjunctive therapy in the treatment of adults living with major depressive disorder (MDD). Ulotaront, which is also being evaluated in Phase 3 clinical development for the treatment of schizophrenia, is the first TAAR1 agonist to be studied as an adjunctive therapy in the treatment of MDD.
The global, multicenter, randomized, double-blind, placebo-controlled study is designed to examine the efficacy, safety and tolerability of ulotaront as an adjunctive therapy in the treatment of adults with MDD. Patients with an inadequate response to current antidepressant treatment will be randomized to receive ulotaront or placebo in addition to their antidepressant therapy.
The primary endpoint for the study is the reduction of depressive symptoms, as measured by the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score, compared to placebo at the end of the study.
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