Reviva Pharmaceuticals has released detailed findings from a year-long open-label extension study evaluating its investigational antipsychotic, brilaroxazine (RP5063), for the treatment of schizophrenia. The results highlight the drug’s potential as a safer and more effective alternative to current antipsychotics.
Study Highlights:
- Efficacy: Brilaroxazine showed sustained improvements in both positive symptoms (e.g., hallucinations, delusions) and negative symptoms (e.g., social withdrawal, lack of motivation) of schizophrenia over the 12-month period.
- Positive symptoms were measured using the Positive and Negative Syndrome Scale (PANSS), with patients demonstrating significant reductions in scores.
- Improvements in cognitive and functional outcomes were also observed, suggesting broader therapeutic benefits.
- Safety and Tolerability:
- One of the standout findings was the drug’s minimal impact on weight gain, a common and problematic side effect of many antipsychotics.
- No significant changes were recorded in metabolic parameters such as blood sugar levels, lipid profiles, or prolactin levels, which are often adversely affected by existing treatments.
- The incidence of extrapyramidal symptoms (movement disorders) was notably low.
- Mechanism of Action: Brilaroxazine is a dopamine-serotonin modulator that targets specific receptor subtypes implicated in schizophrenia. This selective mechanism is believed to contribute to its reduced side effect profile while maintaining efficacy.
Implications for Treatment:
Schizophrenia remains a challenging condition to manage, with many patients discontinuing treatment due to side effects like weight gain, metabolic disturbances, or sedation. Brilaroxazine’s favorable safety profile and efficacy in managing a broad spectrum of symptoms position it as a potential breakthrough in antipsychotic therapy.
Next Steps:
Reviva plans to leverage these findings to progress into Phase III clinical trials. The company is also exploring brilaroxazine’s potential applications for other central nervous system disorders, including bipolar disorder and major depressive disorder.
If approved, brilaroxazine could address critical unmet needs in schizophrenia treatment, offering patients a more tolerable and effective option for long-term symptom management.
