FDA Approves Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults
Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer) announced that the U.S. Food and Drug Administration has approved Exxua (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.
Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain warnings or adverse reactions regarding causing sexual dysfunction or weight gain vs. placebo.
Exxua is expected to be available in pharmacies in early 2024. Exxua is not approved for use in pediatric patients.
