- Intra-Cellular Therapies Inc ITCI shares are gaining nearly 14% Tuesday following topline results from Study 403 evaluating lumateperone 42mg as monotherapy for major depressive episodes in patients with major depressive disorder (MDD) and bipolar depression with mixed features.
- Lumateperone 42mg given once daily met the primary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score (depression scale) compared to placebo at Week 6.
- The combined major depressive disorder (MDD) and bipolar depression with mixed features (5.7 point reduction vs. placebo).
- MDD with mixed features (5.9 point reduction vs. placebo).
- Bipolar depression with mixed features (5.7 point reduction vs. placebo).
- Lumateperone 42mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score compared to the placebo.
- In this study, lumateperone was generally safe and well tolerated. The most commonly reported adverse events were somnolence, dizziness, and nausea.
- In December 2021, the FDA approved lumateperone, brand name Caplyta, for depressive episodes associated with bipolar I or II disorder in adults.
- Bipolar disorders affect approximately 11 million adults in the U.S., and bipolar depression is the most common clinical presentation of the disorder. MDD affects about 21 million adults in the U.S. each year.
- Price Action: ITCI shares are up 13.86% at $54.51 on the last check Tuesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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