Brilaroxazine shows promise for schizophrenia in pivotal phase 3 trial

Key takeaways:

• Brilaroxazine significantly improved schizophrenia symptoms compared with placebo in a trial of 412 patients.
• A new drug application is expected to be submitted to the FDA in 2025.

Brilaroxazine, a potential new treatment for schizophrenia, significantly improved symptoms and was well-tolerated in a pivotal phase 3 trial, according to a press release from its manufacturer.

“We believe the unique multifaceted mechanism of action of brilaroxazine, a serotonin-dopamine signaling modulator, has potential to improve additional key disease drivers like neuroinflammation,” Laxminarayan Bhat, PhD, founder, president and CEO of Reviva Pharmaceuticas, said in the release. He added that the results “highlight the potentially differentiated therapeutic profile of once-daily brilaroxazine and underscore the potential to address treatment limitations for the 24 million people living with schizophrenia around the world.”

The trial of 412 patients, called RECOVER, found that a daily dose of brilaroxazine yielded a 10.1-point greater reduction in total Positive and Negative Syndrome Scale (PANSS) score at 4 weeks compared with placebo, according to the release. The drug also achieved “statistically significant” and “clinically meaningful” results in all major symptom domains and secondary endpoints.

“The consistent response across all primary and secondary endpoints at the 50 mg dose and improvement in all major domains, including negative symptoms and personal and social performance, is strong support for brilaroxazine’s robust activity,” Larry Ereshefsky, PharmD, BCPP, FCCP, a consultant for Reviva, said in the release.

There were no treatment-emergent serious adverse events, drug-related serious adverse events, instances of suicidal ideation or significant changes in body weight. Compared with a 22% discontinuation rate for placebo, 16% of the brilaroxazine 50 mg group and 19% of the brilaroxazine 15 mg group discontinued.

Reviva described brilaroxazine in the release as a “new chemical entity with potent affinity and selectivity against key serotonin and dopamine receptors.” The company says it plans to develop the drug for bipolar disorder, major depressive disorder and ADHD.

Data from an upcoming global confirmatory trial, called RECOVER-2, as well as data from an ongoing open label extension trial, are expected to support a new drug application submission to the FDA in 2025, according to the release.