Sept. 29, 2023 – The FDA has approved a new drug to treat major depressive disorder in adults that does not have common side effects found with other drugs for depression, the Houston-based drug maker Fabre Kramer said in a news release.

The drug will be “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,” the news release said.

Other types of anti-depression medication are known to have side effects like sexual dysfunction and weight gain. The company said the most frequent side effects found in a trial involving 5,000 people were mild and brief periods of dizziness and nausea. 

Exxua should be available in pharmacies by early 2024, the company said. The drug, known in the lab as gepirone hydrochloride, will be sold in tablet form.

The FDA previously turned down applications for the drug three times because of failed studies. 

Michael Pollock, CEO of the Depression and Bipolar Support Alliance, said in the company news release that the number of Americans with major depressive disorder rose during the COVID-19 pandemic, with about 30% of adults in the U.S. having more symptoms of depression.

“The need for new treatment options, particularly those with new mechanisms of action, could not be clearer and more urgent for those living with, or impacted by, major depressive disorder,” he said.

“Exxua represents an important milestone in the treatment of MDD, a serious and debilitating condition that affects millions of people worldwide,” said Stephen Kramer, MD, the CEO of Fabre-Kramer.