Sept. 29, 2023 – The FDA has authorized a brand new drug to deal with main depressive dysfunction in adults that doesn’t have widespread uncomfortable side effects discovered with different medication for melancholy, the Houston-based drug maker Fabre Kramer mentioned in a information launch.
The drug can be “the primary and solely authorized antidepressant with a novel mechanism of motion that selectively targets the serotonin 1A receptor, a key regulator of temper and emotion,” the information launch mentioned.
Different forms of anti-depression treatment are recognized to have uncomfortable side effects like sexual dysfunction and weight acquire. The corporate mentioned essentially the most frequent uncomfortable side effects present in a trial involving 5,000 folks had been delicate and temporary durations of dizziness and nausea.
Exxua needs to be accessible in pharmacies by early 2024, the corporate mentioned. The drug, recognized within the lab as gepirone hydrochloride, can be offered in pill kind.
The FDA beforehand turned down purposes for the drug 3 times due to failed research.
Michael Pollock, CEO of the Melancholy and Bipolar Help Alliance, mentioned within the firm information launch that the variety of People with main depressive dysfunction rose in the course of the COVID-19 pandemic, with about 30% of adults within the U.S. having extra signs of melancholy.
“The necessity for brand new remedy choices, significantly these with new mechanisms of motion, couldn’t be clearer and extra pressing for these residing with, or impacted by, main depressive dysfunction,” he mentioned.
“Exxua represents an vital milestone within the remedy of MDD, a critical and debilitating situation that impacts thousands and thousands of individuals worldwide,” mentioned Stephen Kramer, MD, the CEO of Fabre-Kramer.