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# FDA Approves New Depression Drug
- URL: https://www.fdaweb.com/fda-approves-new-depression-drug/
- Published: 2023-09-28T12:00:00.000Z
- Updated: 2026-09-14T18:58:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155445

FDA has approved a Fabre-Kramer Pharmaceuticals NDA for Exxua (gepirone hydrochloride extended-release tablets) for treating major depressive disorder in adults. Exxua features a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion, according to the company.

In clinical trials, the drug was shown to effectively relieve depressive symptoms with an acceptable side effect profile, the company says. “Sexual side effects experienced with Exxua treatment in clinical trials were comparable to placebo and did not meet the incidence criteria for inclusion in the Adverse Reaction section of Exxua’s label,” it says, adding that it showed no significant adverse effect on weight, blood pressure, heart rate or liver function.