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Intra-Cellular's Lumateperone Brings Mixed Results In Bipolar Depression

 
• By Joseph Haas

Firm will discuss Phase III data with the US FDA, calling results from a successful Phase III monotherapy study robust despite second Phase III study's failure. Lumateperone is under review for schizophrenia, with a 27 September action date.

Bipolar disorder psychological state diagnosis concept, flat vector illustration, expressive happiness and depression, unstable patient mood, contrasting feelings with cheerful and frustrated person - Vector
Bipolar disorder is characterized by episodes of mania and depression

Intra-Cellular Therapies Inc. is optimistic that mixed Phase III results for its novel atypical antipsychotic lumateperone in bipolar depression could be sufficient for approval, especially since the drug demonstrated efficacy in patients with bipolar II disorder, an underserved subpopulation. The candidate met its primary endpoint for improvement in depressive episodes in one Phase III monotherapy study, but did not separate from placebo in a second monotherapy trial.

Lumateperone offers a novel mechanism of action for neuropsychiatric indications as a selective and simultaneous modulator of serotonin, dopamine and...

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