The US Food and Drug Administration (FDA) has approved Gepirone hydrochloride extended-release tablets (Exxua) as the first oral selective 5HT1A receptor agonist for treating major depressive disorder in adults. Exxua, a novel mechanism of action, has been approved without warnings or adverse reactions related to sexual dysfunction or weight gain.
The FDA approval marks a unique accomplishment, as Exxua overcame several obstacles, having been rejected three times before finally receiving the green light. The drug displayed an overall acceptable safety profile in clinical trials, with rates of sexual side effects comparable to that with placebo. There were no significant adverse effects on blood pressure, heart rate, and liver function. Dizziness and nausea were the most commonly reported adverse events in clinical trials, and they were mild, of short duration, related to dose escalations and did not require discontinuation of treatment.
The FDA did not grant approval when the drug was originally submitted, but it was backed by two well-designed randomized controlled trials. The FDA decision is being applauded by many in the field, with patient advocacy groups celebrating the new entry. Exxua should be available to patients in early 2024.