Fabre-Kramer Pharmaceuticals Inc., a biopharmaceutical company developing therapies to address unmet needs in psychiatry and neurology, received approval from the FDA for Exxua (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD).

Exxua represents a new class of 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. 

Studied in over 5,000 patients, EXXUA’s unique mechanism of targeted single serotonin (5HT) 1a receptor agonism relieves depressive symptoms with an acceptable side effect profile. EXXUA showed an overall acceptable safety profile, with no significant adverse effect on weight, blood pressure, heart rate or liver function. The most frequent adverse events seen in clinical trials were dizziness and nausea, which generally were mild, of short duration, related to dose escalations and did not require discontinuation of treatment.