When used as adjunctive therapy with the mood stabilizers lithium or valproate, the schizophrenia drug lumateperone 42 mg improved depressive symptoms in patients with bipolar depression experiencing major depressive episodes, Intra-Cellular Therapies Inc. announced.
The 6-week, phase 3 trial, called Study 402, involved 529 patients with moderate to severe major depressive episodes associated with bipolar I or bipolar II disorder. Participants, who were from 5 countries including the United States, were randomized 1:1:1 to lumateperone 42 mg, lumateperone 28 mg, or placebo in addition to continuing lithium or valproate.
At week 6, once-daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline on the Montgomery-Åsberg Depression Rating Scale total score compared with placebo. Lumateperone 42 mg also met the trial’s key secondary objective of statistically significant improvement on the Clinical Global Impression Scale for Bipolar for Severity of Illness-Depression subscale score, Intra-Cellular Therapies reported. While lumateperone 28 mg showed a trend for a dose-related improvement in depressive symptoms, results did not reach statistical significance.
Consistent with previous trials, lumateperone was generally well-tolerated, with a favorable safety profile. The most commonly reported adverse events were somnolence, dizziness, and nausea.
Based on the findings from this and a previous phase 3 monotherapy study (Study 404), Intra-Cellular Therapies said it plans to submit a supplemental new drug application (sNDA) to the US Food and Drug Administration in late 2020 or early 2021 for the use of lumateperone to treat bipolar depression in patients with bipolar I or II disorder as monotherapy and adjunctive therapy.
“Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone’s label to include a second major neuropsychiatric disorder,” said Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies. “With this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia.”
Intra-Cellular Therapies announces positive topline results from study 402 evaluating lumateperone as adjunctive therapy in patients with bipolar depression [press release]. New York, New York: Intra-Cellular Therapies; September 9, 2020.