FDAapproves the first rapid-acting oral drug for major depression PsychTwitter
-aspartate receptor antagonist for the treatment of major depressive disorder in adults, its manufacturer has announced.It is the"first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at one week," the company said in a news release.
"Given the debilitating nature of depression, the efficacy of Auvelity observed at 1 week and sustained thereafter may have a significant impact on the current treatment paradigm for this condition," he said. The company noted the drug was studied in a comprehensive clinical program that included more than 1100 patients with MDD.
The efficacy of the drug was demonstrated in the GEMINI placebo-controlled study — with confirmatory evidence provided by the ASCEND study, which compared it withAxsome said it expects to launch the new oral medication in the fourth quarter of this year. It is not approved for use in children.
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