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FDA Approves New Atypical Antipsychotic, Caplyta

Posted by PeterMartin on December 23, 2019, at 21:54:26

December 23, 2019:

The exact mechanism of action of Caplyta in the treatment of schizophrenia is unknown, but it is believed to be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

The approval was based on results from 2 double-blind, placebo-controlled trials (Study 1 [N=335] and Study 2 [N=450]) that evaluated the efficacy of Caplyta in patients with schizophrenia for 28 days. Findings from Study 1 and Study 2 showed that Caplyta 42mg once daily demonstrated a statistically significant reduction from baseline to Day 28 in the Positive and Negative Syndrome Scale (PANSS) total score with a placebo-subtracted difference of -5.8 (95% CI: -10.5, -1.1) and -4.2 (95% CI: -7.8, -0.6), respectively.





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