Newron Pharmaceuticals has reported substantial additional data from its study 014/015 of evenamide, as an add-on to an antipsychotic medication for the treatment of moderate-to-severe treatment-resistant schizophrenia (TRS).
The international, randomised, open-label, rater-blinded study describes the usage of evenamide, as an add-on to an antipsychotic (excluding clozapine) in TRS patients who did not respond to their current antipsychotic medication.
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It is being conducted at multiple sites in India, Italy and Sri Lanka.
The study demonstrated that evenamide when added to antipsychotics was well tolerated with minimal occurrence of treatment-emergent adverse events.
More than 90% of the patients who completed the study chose to continue with evenamide in the long-term extension study (study 015). Till now, 97% of patients have completed six weeks of treatment.
Improvement was also observed in all Positive and Negative Syndrome Scale (PANSS) subscales at six weeks, including negative symptoms.
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By GlobalDataNewron Pharmaceuticals chief medical officer Ravi Anand said, “The multi-modal-benefits observed across various domains with evenamide also validate extensive academic research, suggesting that TRS results from excessive glutamate signalling.
“Moreover, the gradual and continuous improvement in symptoms over time is unique to treatment with evenamide.
“We plan to initiate Study 003, a potentially pivotal, multinational, randomized, placebo-controlled trial in patients with TRS later this year and are confident that the results from that study will support the need for re-evaluation of the current therapeutic strategy for managing patients with TRS.”
The orally administered, Evenamide specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other central and peripheral nervous system (CNS) targets.
