September 29, 2023 – The FDA has approved a brand new drug to treat major depressive disorder in adults that doesn't have the common unwanted side effects of other depression medications, Houston-based drugmaker Fabre Kramer said in a news release.
The drug can be “the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, an important regulator of mood and emotions,” the press release said.
Other forms of medications for depression are known to have unwanted side effects similar to sexual dysfunction and weight gain. The company said probably the most common unwanted side effects present 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 due to failed trials.
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 would have.
“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.