FDA Approves Extended-Release Therapy for Major Depression


Exxua is approved to treat adults with major depressive disorder, but its labeling does not contain warnings about sexual function or weight gain.

The FDA has approved Exxua (gepirone) extended-release tablets to treat adults with major depressive disorder (MDD). Exxua is expected to be available in early 2024.

Major depressive disorder is characterized by low mood, inability to feel pleasure, feelings of worthlessness, and impairment of important functioning. In severe cases, MDD can result in suicide. An estimated 21 million, or about 8.3%, of U.S. adults experience a major depressive event each year, according to the National Institute of Mental Health.

Michael Pollack

Michael Pollack

“The mental health crisis in the United States is one of the most pressing health issues facing our country today,” Michael Pollack, CEO of the Depression and Bipolar Support Alliance, said in a press release. “More than 20 million American adults experienced major depressive disorder each year prior to the COVID-19 pandemic. These numbers increased dramatically during the pandemic with about 30% of adults in the United States or more than 80 million Americans experiencing elevated symptoms of depression.”

Developed by Fabre-Kramer Pharmaceuticals, Exxua is a first-in-class of antidepressant that targets the serotonin 1A receptor, a key regulator of mood and emotion. A spokesperson for Fabre-Kramer said final pricing has not been determined yet but Exxua will be competitive with other branded antidepressants. The company expects formulary placement to also be consistent with newer branded antidepressants, such as Auvelity (dextromethorphan-bupropion), which was approved in August 2022. (Auvelity has a retail price according to GoodRx of about $1,000 for 60 tablets, and it appears that payers may require step therapy and/or prior authorization.)

Related: FDA Approves Rapid-Acting Auvelity for Major Depression

The approval of Exxua was based on data from two pivotal trials. In two eight-week placebo-controlled studies, an effect was generally observed starting at week 2 and increased in subsequent weeks with the full antidepressant effect generally not seen until week 3 or later. In the open label phase of up to 12 months, patients receiving Exxua had a statistically significantly lower relapse rate (24.0%) compared with placebo (38.7%). Time to relapse was also statistically significantly longer in patients treated with Exxua.

Common adverse events included of headache, transient dizziness at dose escalations, nausea, and insomnia. Although dizziness is the most common adverse experience reported compared with placebo, the majority of such events were mild to moderate in severity, dose-related, and 3% led to discontinuation of treatment.

Exxua’s labeling does not contain warnings or adverse reactions regarding causing sexual dysfunction or weight gain.

In late 2021, the FDA required safety labeling on all SSRI and SNRI products warning about the risk sexual dysfunction. In January 2023, Fabre-Kramer amended its NDA and provided the agency with data about Exxua’s effect on sexual function. Analysis of data from a group of clinical trials with measures of sexual function demonstrated that Exxua has no negative effect on sexual function and showed a distinct advantage over SSRIs that are commonly associated with sexual dysfunction.

Anita H. Clayton, M.D., chair, Department of Psychiatry & Neurobehavioral Sciences, University of Virginia School of Medicine, said in a press release at the time that the prevalence of sexual dysfunction is a major issue in treatment of MDD, and a treatment option without the sexual side effects has been needed for a long time.

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