The drug company announced that Exxua is the first authorized antidepressant for MDD.
“There is value in providing prescribers and patients with a wide range of effective options for use in clinical practice. We are proud to bring this innovative therapy to patients who need a new option to manage their depression and improve their quality of life,” Kramer added.It specifically targets the serotonin 1A receptor, which plays a role in regulating mood and emotions.
Reportedly, the drug's approval was based on the results of 8-week clinical studies. These randomized, double-masked, placebo-controlled studies included outpatients aged 18 to 69 who met the criteria for MDD. In the studies, gepirone ER outperformed the placebo. The antidepressant had no substantial detrimental effects on blood pressure, heart rate, or liver function. Mild dizziness and nausea were the most prevalent adverse effects found in clinical studies, usually of brief duration, associated with dosage increases, and not requiring treatment termination.One of the most common mental diseases in the United States is significant depression.
Before the COVID-19 pandemic, more than 20 million American adults annually faced major depressive disorder, as per the release.
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