FDA approves treatment for major depression

The U.S. Food and Drug Administration approved lumateperone in adult patients with major depressive disorder.

The drug received FDA approval after demonstrating efficacy as adjunctive therapy with antidepressants in the Phase 3 501 and 502 trials as well as a safety profile consistent with previous indications for schizophrenia and bipolar depression, according to a news report from PR Newswire. In an extension safety study, researchers found that about 65% of the patients who received lumateperone achieved remission.

Read more: PR Newswire

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