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Intra-Cellular Therapies Discloses New Drug Candidate For Dementia Related Episodes

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  • Intra-Cellular Therapies Inc (NASDAQ: ITCIexpands its pipeline with a new molecular entity, ITI-1284, a sublingually delivered deuterated form of lumateperone.
  • ITI-1284 has been developed in collaboration with Catalent Inc (NYSE: CTLT), using its proprietary Zydis ODT (orally disintegrating tablet) fast-dissolving formulation.
  • The company completed Phase 1 studies that showed ITI-1284 ODT-SL was rapidly absorbed into the systemic circulation, was metabolically stable, and resulted in high systemic exposure.
  • No serious adverse events were reported. In the elderly cohort, reported adverse events were infrequent, with the most being transient dry mouth (mild).
  • Intra-Cellular plans to develop ITI-1284 ODT-SL to treat behavioral disturbances in patients with dementia-related psychosis and certain depressive disorders in the elderly.
  • Yesterday, the company filed a supplemental marketing application for CAPLYTA (lumateperone) to the FDA for depressive episodes associated with bipolar I or II disorder in adults.
  • Price Action: ITCI shares are up 1.76% at $37.54 on the last check Wednesday.
 

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Posted-In: dementia Phase 1 TrialBiotech News Health Care FDA General

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