The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Applications (sNDAs) for lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder, as monotherapy and as adjunctive therapy with lithium or valproate.
The sNDA submissions are supported by data from 2 global randomized, double-blind, placebo-controlled phase 3 studies (Study 404 [ClinicalTrials.gov: NCT03249376] and 402 [ClinicalTrials.gov: NCT02600507]) that evaluated the efficacy and safety of lumateperone as monotherapy and adjunctive therapy with lithium or valproate, respectively, in adults with bipolar depression. In Study 404, 381 patients were randomly assigned 1:1 to receive lumateperone 42mg orally once daily or placebo; Study 402 included 529 patients who were randomly assigned 1:1:1 to receive lumateperone 42mg, 28mg, or placebo.
Findings from both studies showed that lumateperone was associated with statistically significant improvements on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, the Clinical Global Impression Scale for Bipolar for Severity of Illness-Depression subscale (CGI-BP-S) total score, and the CGI component that assesses depression (CGI-BP-S Depression Score). As for safety, the most common adverse events reported in both studies were somnolence, dizziness and nausea. The rates of akathisia, restlessness and extrapyramidal symptoms with lumateperone were low and similar to placebo.
A Prescription Drug User Fee Act (PDUFA) target date of December 17, 2021 has been set for these applications.
Lumateperone, an atypical antipsychotic, is marketed under the brand name Caplyta® and is currently approved for the treatment of schizophrenia in adults.
Intra-Cellular Therapies announces FDA acceptance of Caplyta® (lumateperone) sNDAs for the treatment of bipolar depression. [press release]. New York, NY: Intra-Cellular Therapies, Inc; May 3, 2021.