FDA approves antidepressant not linked to sexual dysfunction, weight gain

Key takeaways:

• Exxua, a selective serotonin 1A receptor agonist, has been approved for major depressive disorder in adults.
• The drug is not linked to sexual dysfunction or weight gain vs. placebo.

The FDA has approved Exxua, an oral selective 5HT1a receptor agonist for the treatment of major depressive disorder in adults.

Exxua (gepirone hydrochloride) works through a novel method of targeted single serotonin 1A receptor agonism and is the first of its kind to be approved by the FDA, according to a press release from manufacturer Fabre-Kramer Pharmaceuticals. The extended-release tablets are expected to be available in pharmacies early 2024.

Stephen Kramer, MD, CEO of Fabre-Kramer, said in the release that “Exxua represents an important milestone in the treatment of [major depressive disorder].”

The drug is “the first truly selective agonist of the serotonin 1A receptor that has been consistently linked to mediation of mood disorders and suicide risk,” Stephen M. Stahl, MD, PhD, psychiatry professor at the University of California and founder of the Neuroscience Education Institute, said in the release.

Gepirone hydrochloride has been studied in more than 5,000 patients and was shown to relieve depression symptoms. Sexual side effects did not occur frequently enough for inclusion as an adverse reaction on the product’s label, and there were no significant adverse effects on weight, blood pressure, heart rate or liver function, according to the release.

Its mechanism of action “is not fully understood but is believed to be related to its modulation of serotonin activity in the CNS through selective agonist activity at [serotonin 1A] receptors,” the release stated.

In clinical trials, the most common adverse events were dizziness and nausea. Symptoms generally were mild, brief, associated with dose escalations and did not require stopping treatment.