Intra-Cellular extends Caplyta's success towards $5B sales goal

Intra-Cellular Therapeutics has recently highlighted Caplyta (lumateperone) as a potential major sales driver, predicting it could generate $5 billion in revenue within the next decade. On Tuesday, the company announced a significant achievement in another Phase III clinical trial, demonstrating success for Caplyta as a maintenance treatment for adults with schizophrenia.

Caplyta originally received FDA approval in 2019 as a daily oral medication for schizophrenia. Its indications were expanded in 2021 to include bipolar depression. Since its release, Caplyta's sales have shown consistent growth and are projected to reach between $665 million and $685 million this year, with recent forecasts being revised upward.

The potential for Caplyta's revenue could increase even more if it secures approval for major depressive disorder (MDD). The drug has shown promising results in this area with positive outcomes in Study 501 and Study 502 earlier this year. A marketing application for MDD is expected to be submitted in the current quarter, and the medical community is eagerly awaiting the approval, as indicated by positive feedback from psychiatrists.

The latest data comes from Study 304, involving 228 patients with schizophrenia who had been stabilized on Caplyta. These patients were then randomly assigned to continue with Caplyta or switch to a placebo for up to 26 weeks. The results were encouraging, showing that patients who continued on Caplyta had a 63% lower risk of relapse compared to those on placebo, thus achieving the primary goal of the study.

Intra-Cellular Therapeutics reported that there were 18 relapses (16.4%) in the Caplyta group compared to 44 relapses (38.6%) in the placebo group. Additionally, Caplyta met the secondary endpoint of time to all-cause discontinuation during the randomized phase of the trial.

Caplyta's increasing success and expanded indications underscore its potential as a robust therapeutic option for patients with schizophrenia and possibly other mental health conditions in the future.