Ahead of the FDA’s decision on Bristol Myers Squibb’s schizophrenia treatment KarXT, the Big Pharma has kicked off a campaign this week to improve education around and destigmatize the mental illness while also providing helpful resources for patients.
An experimental drug from Karuna Therapeutics has succeeded in a second late-stage clinical trial testing it as a potential therapy for schizophrenia.
MIAMI--(BUSINESS WIRE)--Segal Trials, a privately held network of clinical research sites throughout South Florida has concluded a phase 3 EMERGENT-2 trial with Karuna Therapeutics. The study focused on evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia. The study was overseen by Segal Trials, Chief Scientific Officer, & Principal Investigator, Rishi Kakar, MD.
Karuna announces positive results from Phase III trial into schizophrenia
SHANGHAI and SAN FRANCISCO and CAMBRIDGE, Mass., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the company’s partner, Karuna Therapeutics, Inc. (NASDAQ: KRTX), reported positive topline results from its Phase 3 EMERGENT-2 trial evaluating the efficacy, safety, and tolerability of its lead investigational therapy, KarXT (xanomeline-trospium), in adults with schizophrenia. The trial met its primary endpoint, with KarXT demonstrating a statistically significant and clinically meaningful 9.6-point reduction in the Positive and Negative Syndrome Scale (PANSS) total score compared to placebo (-21.2 KarXT vs. -11.6 placebo, p<0.0001) at Week 5 (Cohen’s d effect size of 0.61). KarXT also demonstrated an early and sustained statistically significant reduction of symptoms, as assessed by PANSS total score, starting at Week 2 and maintained such reduction through all timepoints in the trial.
Drug firm GranulesNSE 4.20 % India on Friday said it has received approval from the US health regulator for generic Trospium Chloride extended-release capsules used for the treatment of overactive bladder.