Monday, October 2, 2023

FDA Approves Exxua for Treatment of Major Depression in Adults

The Food and Drug Administration (FDA) late last month approved a medication called Exxua (gepirone) for the treatment of major depression in adults. (Gepirone is in the same class of medications as the anti-anxiety medication buspirone.)

The medication, available in extended-release tablets, is “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,” according to a press release by the Fabre-Kramer Pharmaceuticals, maker of Exxua.

The FDA approval was based, in part, on two eight-week randomized, double-blind, placebo-controlled clinical trials of adults aged 18 to 69. Both studies included flexible dosing of Exxua from 18.2 mg to 72.6 mg daily. By the end of both trials, participants taking Exxua reported statistically greater reductions in depressive symptoms compared with participants in the placebo group (about a 2.5-point difference in scores on the 17-item Hamilton Depression Rating Scale).

The safety of Exxua was evaluated in over 5,000 patients, according to Fabre-Kramer Pharmaceuticals. The side effects of Exxua appeared similar to those of placebo in terms of sexual side effects, weight gain, blood pressure, heart rate, and 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,” according to the release.

Nominations Invited for New Council on Women’s Mental Health

The new Council on Women’s Mental Health will become an official APA component in May 2024, replacing the Committee on Women’s Mental Health. APA members are invited to nominate themselves or a colleague with expertise in the council’s content area to reflect the breadth of diversity within the membership. The deadline is Wednesday, November 15.