Caplyta(lumateperone)

Caplyta (lumateperone) is an approved oral capsule for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, both as monotherapy and as adjunctive therapy with lithium or valproate. The primary efficacy endpoint for this indication was the change from baseline in the MADRS total score to Day 43. Key secondary efficacy endpoints included the change from baseline in the CGI-BP-S-Depression score and the CGI-BP-S total score to Day 43.

Efficacy results showed a MADRS Total Score LS mean difference vs placebo of -4.6 and -2.4 (42mg arm). The CGI-BP-S Depression Score p-value for the 42mg arm was 0.0082, and the CGI-BP-S Total Score p-value was <0.0001. Safety findings include an increased mortality risk (1.6 to 1.7 times) in elderly patients with dementia-related psychosis treated with antipsychotic drugs. In an uncontrolled open-label trial for up to 1 year in patients with stable schizophrenia, 4.7% of patients with normal hemoglobin A1c (<6.5%) at baseline developed elevated levels (≥6.5%) post-baseline. Mean change in body weight at Day 175 in patients with bipolar depression was -0.01 kg. The frequency of orthostatic hypotension for Caplyta in short-term, placebo-controlled schizophrenia trials was 0.7%, compared to 0% for placebo. The incidence of extrapyramidal symptoms was around 1%.