Intra-Cellular Therapies, Inc. reported positive results on 16 April from the first Phase III clinical trial of Caplyta (lumateperone) in major depressive disorder (MDD) that exceeded expectations for the study and increased speculation that the drug would add to the drug’s blockbuster potential. Assuming a second Phase III trial in MDD is positive when it reads out late in the second quarter of 2024, the company plans to file for supplemental approval in the third indication later this year.
Key Takeaways
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Intra-Cellular Therapies reported positive results from the first Phase III study of Caplyta (lumateperone) as an adjunct to antidepressant therapies in major depressive disorder (MDD).
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The placebo-adjusted results beat expectations and the company’s stock price surged as MDD may add blockbuster sales on top of approved schizophrenia and bipolar depression indications
The US Food and Drug Administration approved the atypical antipsychotic Caplyta for adults with schizophrenia in December 2019 and as a monotherapy or in combination with lithium or valproate for adults with depressive episodes associated bipolar I or II disorder in December 2021. (Also see "Intra-Cellular's Lumateperone Poised For New Bipolar Depression Opportunity" - Scrip, 10 September, 2020.) The drug generated $462