FDA Approves Intra-Cellular's Antipsychotic For Bipolar Depression

  • The FDA has approved Intra-Cellular Therapies Inc ITCI Caplyta for depressive episodes associated with bipolar I or II disorder in adults.
  • The approval for Caplyta comes as monotherapy and as adjunctive therapy with lithium or valproate.
  • The drug has shown a favorable profile on weight, cardiometabolic parameters, and extrapyramidal symptoms (movement disturbances). 
  • Related content: Benzinga's Full FDA Calendar.
  • The Company says it is positioned to launch the drug immediately.
  • The approval is based on two positive Phase 3 studies, which demonstrated statistically significant improvements over placebo for the change from baseline in the Montgomery-Asberg Depression Rating scale (MADRS) total score at week 6. 
  • Caplyta 42 mg also showed a statistically significant improvement in the key secondary endpoint relating to the clinical global impression of bipolar disorder in each study.
  • Price Action: ITCI shares are up 19.3% at $46.72 during the premarket session on the last check Monday.
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