Lumateperone Demonstrates Positive Efficacy for Schizophrenia Relapse Prevention

Lumateperone (Caplyta; Intra-Cellular Therapies), a second-generation antipsychotic, demonstrated positive safety and efficacy results in Study 304, a trial evaluating the treatment for the prevention of relapse in adult patients with schizophrenia.^1,2

Schizophrenia can be a major burden for patients who relapse or have not found success with other medications. | Image Credit: © Olivier Le Moal | stock.adobe.com

The oral, once daily, 42 mg antipsychotic has previously been FDA-approved for the treatment of schizophrenia and for the treatment of depressive episodes associated with bipolar I or II disorder as a monotherapy or adjunctive therapy with lithium or valproate in adults.^3,4

Now, the treatment has shown significant efficacy in preventing relapse in patients with schizophrenia. The primary end point, time to relapse during the double-blind treatment phase, was found to be significantly longer in patients who received lumateperone compared with those who received placebo, according to the trial results.¹

“We are very pleased that the results from Study 304, a randomized withdrawal trial, demonstrated efficacy along with favorable safety and tolerability which support the benefit of continued long-term treatment with lumateperone,” Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies, said in a news release.¹

Study 304, a multicenter, randomized, double-blind, placebo-controlled trial, evaluated lumateperone for the prevention of symptomatic relapse in adults with schizophrenia. Lasting 47 weeks, the trial included an 18-week open-label phase in which patients were treated with lumateperone 42 mg per day. Patients meeting key stabilization criteria progressed to the double-blind treatment phase, when they were randomized to continue lumateperone 42 mg or switched to placebo for up to 26 weeks or until relapse occurred.¹

In the lumateperone group, only 18 relapses (16.4%) were reported, compared with 44 relapses (38.6%) in the placebo group. Importantly, treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo (HR: 0.37; 95% CI, 0.22-0.65).¹

A key secondary end point—time to all cause discontinuation during the double-blind phase—was also met by lumateperone. The treatment was generally well-tolerated and safe among the trial participants; the most reported adverse event in the double-blind phase observed at a rate greater than or equal to 5%, and twice the rate of placebo, was headache, according to the investigators.¹

“Schizophrenia is a chronic, serious mental illness characterized by the occurrence of acute psychotic episodes that cumulatively worsen disease prognosis,” Durgam said. “The control of symptoms and the prevention of relapses is critical to improving long-term patient outcomes.”¹

Based on these positive results, lumateperone could be beneficial to patients who may have failed other second-generation antipsychotics. However, this role must be further evaluated in clinical trials.²

Pharmacists should be aware of the potential adverse reactions to lumateperone and educate themselves on the patients that stand to benefit most from treatment. Critically, lumateperone is contradicted for individuals with known hypersensitivity to the drug or any components featured in it. Knowledge of a patient’s safety profile and any underlying sensitivities to the drug’s components should be top-of-mind.³

REFERENCES

1. Intra-Cellular Therapies. Intra-Cellular Therapies announces positive topline results in phase 3 trial evaluating Caplyta for the prevention of relapse in patients with schizophrenia. News Release. Released November 5, 2024. Accessed November 8, 2024. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-announces-positive-topline-results-2

2. Foroghi H, Basinger R. Clinical overview: A novel way of treating schizophrenia. Pharmacy Times. Published June 8, 2023. Accessed November 8, 2024. https://www.pharmacytimes.com/view/clinical-overview-a-novel-way-of-treating-schizophrenia

3. Gallagher A. FDA approves 2 dose strengths of Caplyta for treatment of schizophrenia. Pharmacy Times. Published April 26, 2022. Accessed November 8, 2024. https://www.pharmacytimes.com/view/fda-approves-2-dose-strengths-of-caplyta-for-treatment-of-schizophrenia

4. Antrim A. FDA approves lumateperone for the treatment of bipolar depression. Pharmacy Times. Published December 20, 2021. Accessed November 8, 2024. https://www.pharmacytimes.com/view/fda-approves-lumateperone-for-the-treatment-of-bipolar-depression