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Intra-Cellular's Lumateperone Poised For New Bipolar Depression Opportunity

 
• By Jessica Merrill

The company is on track to file an sNDA for lumateperone after a Phase III clinical trial met the primary endpoint in bipolar I and II disorder.

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Intra-Cellular hopes to differentiate in bipolar depression • Source: Shutterstock

Intra-Cellular Therapies, Inc. is poised to file a supplemental new drug application for lumateperone for the treatment of depressive episodes in bipolar I and II disorder, the most common clinical presentation of the mental health condition, after completing a final pivotal trial in the indication.

Intra-Cellular said when it announced positive data from a third Phase III trial testing lumateperone in bipolar depression on 9 September that it is on track to file an sNDA in late 2020 or early 2021

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