Newly Approved MDD Drug Does Not Appear to Increase Risk of Sexual Dysfunction

The US Food and Drug Administration (FDA) recently approved Exxua (gepirone hydrochloride extended-release [ER] tablets) for the treatment of major depressive disorder (MDD) in adults, maker Febre-Kramer Pharmaceuticals recently announced.

As the only approved antidepressant that selectively targets the serotonin 1a receptor, a key regulator of mood and emotion, Exxua represents a new class of antidepressant, the biopharmaceutical company stated. Its approved labeling does not contain warnings or adverse reactions regarding sexual dysfunction or weight gain.

Studied in over 5000 patients, Exxua demonstrated effectiveness for relieving depressive symptoms with an acceptable side effect profile. In clinical trials, sexual side effects experienced with Exxua were comparable to placebo.

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“I am thrilled for our patients that Exxua (gepirone ER) is now FDA approved for the treatment of MDD,” said Anita H. Clayton, MD, chair of the department of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine, Charlottesville, Virginia, whose clinical and research expertise involves sexual dysfunction issues in MDD treatment. “Exxua is the first 5-HT1a agonist with superior efficacy vs placebo as MDD monotherapy, yet did not differ from placebo in rates of sexual dysfunction in clinical trials. This provides an important new treatment option for patients.”

Exxua also showed no significant adverse effects on weight, blood pressure, heart rate, or liver function. Dizziness and nausea, which generally were mild, of short duration, and related to dose escalations, were the most frequent adverse events with Exxua in clinical trials.

Exxua is expected to be available in pharmacies in early 2024, according to Febre-Kramer Pharmaceuticals.

Reference

Fabre-Kramer Pharmaceuticals announces FDA approval of EXXUA™, the first and only oral selective 5HT1a receptor agonist for the treatment of major depressive disorder in adults. News release. Fabre-Kramer Pharmaceuticals; September 28, 2023. Accessed October 16, 2023.