Intra-Cellular Therapies reports positive phase 3 results for schizophrenia relapse prevention

Intra-Cellular Therapies has announced favorable outcomes from a phase 3 clinical trial assessing Caplyta (lumateperone) as a maintenance therapy to avert relapse in adult patients with schizophrenia. The research demonstrated a notable enhancement in the duration to relapse for individuals receiving lumateperone compared to those on a placebo, thereby underscoring the prospective effectiveness of lumateperone in the sustained management of schizophrenia.

This investigation, referred to as Study 304, was structured as a randomized withdrawal trial. During the study, patients who had achieved stability on lumateperone were either maintained on the drug or transitioned to a placebo. The findings indicated that 16.4% of those continuing lumateperone experienced a relapse, in stark contrast to 38.6% of patients who were shifted to the placebo group. This data represents a 63% diminution in the risk of relapse for participants on lumateperone.

Additionally, lumateperone succeeded in its principal secondary objective, demonstrating a prolonged period before discontinuation for any reason when compared to the placebo. The safety profile of the treatment showed it was mostly well tolerated by participants, with headache emerging as the most frequently reported side effect, occurring at a significantly higher rate than in the placebo cohort.

Caplyta is already sanctioned for the treatment of both schizophrenia and bipolar depression in adults. The medication is under continued investigation for its potential advantages in managing other psychiatric and neurological disorders.