September 29, 2023 – The FDA has approved a latest 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 can 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 sorts of antidepression medications are known to have unintended effects similar to sexual dysfunction and weight gain. The company said probably the most common unintended effects seen in a study of 5,000 people were mild and temporary periods of dizziness and nausea.
Exxua needs 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 already rejected applications for the drug thrice on account of failed studies.
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 in the course of the COVID-19 pandemic, with about 30% of U.S. adults experiencing more symptoms of depression had.
“The need for new treatment options, particularly those with new mechanisms of action, could not be clearer or 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 Stephen Kramer, MD, CEO of Fabre-Kramer.