September 29, 2023 – The FDA has approved a brand new drug to treat major depressive disorder in adults that doesn’t have any of the unintended effects common with other depression medications, Houston-based drugmaker Fabre Kramer said in a press release.
The drug will likely be “the first and only approved antidepressant with a novel mechanism of action that specifically targets the serotonin 1A receptor, an important regulator of mood and emotion,” the press release said.
Other kinds of antidepressants could cause unintended effects akin to sexual dysfunction and weight gain. The company said essentially the most common unintended effects seen in a study of 5,000 people were mild and temporary periods of dizziness and nausea.
Exxua is predicted to be available in pharmacies in early 2024, the corporate said. The drug, known within the laboratory as gepirone hydrochloride, is sold in tablet form.
The FDA had previously rejected applications for the drug 3 times since the studies had failed.
Michael Pollock, CEO of the Depression and Bipolar Support Alliance, said in the corporate's press release that the variety of Americans with major depressive disorder has increased through the COVID-19 pandemic, with about 30% of U.S. adults experiencing 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 affected by major depressive disorder,” he said.
“Exxua represents an important milestone in the treatment of MDD, a serious and debilitating disease that affects millions of people worldwide,” said Dr. Stephen Kramer, CEO of Fabre-Kramer.