Negative Symptoms of Schizophrenia: A Promising Approach

Schizophrenia, a chronic mental disorder characterized by hallucinations, delusions, disorganized thinking, and negative symptoms, has been a significant burden to patients and families for decades. The management of schizophrenia often involves antipsychotics, which can have limited efficacy in controlling the disease's debilitating symptoms. Recent studies suggest that brilaroxazine, a novel drug targeting serotonin-dopamine signaling, may offer a new approach to treating negative symptoms of schizophrenia.

The RECOVER trial, a pivotal phase 3 study, evaluated the safety and efficacy of brilaroxazine in patients with acute schizophrenia. The study enrolled 411 participants who were randomly assigned to receive either 15 mg or 50 mg of brilaroxazine, or a placebo. The primary endpoint was the change in Positive and Negative Assessment Scale (PANSS) score from baseline to day 28. Secondary endpoints included positive and negative symptoms, social cognition, excitement/agitation, personal and social performance, clinical global impression severity, safety, and emergent adverse events.

The results of the RECOVER trial showed that both 15 mg and 50 mg doses of brilaroxazine significantly reduced symptoms of acute schizophrenia compared to placebo. Notably, the 50 mg dose achieved a 10.1-point reduction in PANSS score compared to placebo (-23.9 vs -13.8). Additionally, significant reductions were observed in positive and negative symptoms.

The mechanisms underlying the therapeutic effects of brilaroxazine are thought to involve its ability to control inflammatory cytokines, which can drive disease progression. As an antagonist at 5-HT2B/7 receptors, brilaroxazine may also modulate anti-inflammatory processes in the brain.

Larry Ereshefsky, PharmD, chief scientific officer at CenExcel Research and Follow the Molecule, emphasized the potential of brilaroxazine as a novel treatment approach. 'I'm an advocate for ways to treat the brain other than receptor blockade,' he said. 'The area of neuroinflammation and damage done by inflammatory stress processes is really gaining support for Parkinson's, depression, Alzheimer's, and serotonin seems to modulate the anti-inflammatory processes in the brain.'

While these findings are promising, further research is needed to confirm the efficacy of brilaroxazine at different doses. The next step in this journey involves testing out a 30 mg dose of brilaroxazine for acute schizophrenia, as required by the US Food and Drug Administration.

In conclusion, the RECOVER trial offers encouraging evidence that brilaroxazine may be an effective treatment approach for negative symptoms of schizophrenia. As researchers continue to explore its potential, patients and families affected by this devastating disorder can remain hopeful about the prospect of improved management options in the future.

Negative symptoms of schizophrenia 5 as