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First Phase III Depression Data For Intra-Cellular’s Caplyta Exceed Expectations

Add-On To Schizophrenia, Bipolar Depression Indications

 
• By Mandy Jackson

With positive results from the first Phase III trial of lumateperone in major depressive disorder and a second readout expected later this quarter, the company plans a supplemental filing in late 2024.

Depiction of fear, loneliness, depression, abuse, addiction
Lumateperone met the primary and secondary endpoints in MDD • Source: Shutterstock

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

  • 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).

    • ...

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...

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