Evenamide boosts symptom improvement in treatment-resistant schizophrenia
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Key takeaways:
- Evenamide was associated with clinically significant improvements in treatment-resistant schizophrenia at 6 months.
- The investigational drug is intended as an adjunct to antipsychotics.
Evenamide, an investigational drug for treatment-resistant schizophrenia, was linked with “increasing, sustained and clinically significant” symptom improvements in a recent study, according to a manufacturer press release.
The voltage-gated sodium channel blocker, by Newron Pharmaceuticals, was associated with statistically significant improvements in all key efficacy measures and was well-tolerated, with few treatment-emergent adverse events, the release stated. The investigational drug, which modulates glutamate release, is intended as an adjunct for patients who respond poorly to existing antipsychotics, including clozapine.
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“What is remarkable about the effect of evenamide in this study is that treatment benefits continue to accrue over time, and many patients who do not respond early achieve clinically important benefits later,” Ravi Anand, chief medical officer at Newron and an author on the study, said in the release. “Importantly, over the course of the study period, we found that no patients relapsed or experienced worsened psychosis, and a significant portion of patients improved to the point that they no longer met the criteria to enroll in the study to begin with.”
The study enrolled 161 patients with treatment-resistant schizophrenia across multiple sites in India, Italy and Sri Lanka. At 6 weeks, 94% chose to continue into a long-term extension study, and 92% completed 6 months of treatment.
There was “gradual and sustained improvement” across all measures of efficacy, according to the release. Statistically significant improvement was seen at 6 months in Positive and Negative Syndrome Scale, Clinical Global Impression of Severity and Strauss-Carpenter Levels of Functioning. Notably, approximately 40% of patients no longer met “the protocol severity criteria used to diagnose treatment resistance” after 6 months of treatment.
According to Anand, given the “highly encouraging results” of this study, the company plans to initiate a “potentially pivotal” 1-year international phase 3, double-blind, randomized controlled trial in patients with treatment-resistant schizophrenia.
He said Newron is “confident” the results will “endorse the use of evenamide as an adjunct treatment to any other antipsychotic as a new therapeutic strategy for [treatment-resistant schizophrenia].”