Adjunctive Evenamide effective, safe for schizophrenia

Newron Pharmaceuticals recently announced positive phase 2a study findings for Evenamide, an oral sodium channel blocker, in individuals with schizophrenia.

To assess tolerability, safety and efficacy of Evenamide as an adjunctive treatment for schizophrenia, researchers conducted a 4-week, phase 2a, double-blind, placebo-controlled randomized study among 89 individuals with schizophrenia. Study participants had experienced breakthrough psychotic symptoms while on stable and adequate doses of risperidone or aripiprazole. The study was conducted in two U.S. and three Indian centers. Mean duration of illness was 18 years with an average of three hospitalizations. In addition to an antipsychotic, participants received 15 mg to 25 mg of Evenamide or placebo twice daily.

Positive and Negative Syndrome Scale (PANSS) scores and Strauss-Carpenter Level of Functioning Scale scores improved among participants who received Evenamide, compared with their standard antipsychotic.

Clinical Global Impression of Change scores improved among 54% of participants who received Evenamide and 36% who received placebo.

Evenamide was well-tolerated, according to a press release. Most frequent adverse events were somnolence (16% vs. 12.8%), insomnia (10% vs. 2.6%), overdose (6% vs. 2.6%), dry mouth (6% vs. 5.1%) and headache (6% vs. 0%).

Skin and subcutaneous adverse events were more common in participants who received Evenamide.

Most adverse events were mild (84%) or moderate (13%) among participants who received Evenamide.

Two participants who received Evenamide discontinued due to seizure and atrial fibrillation.

“The results of this study are very encouraging,” Ravi Anand, MD, chief medical officer of Newron, said in a press release. “Evenamide was not associated with any dose-limiting toxicities, or the extrapyramidal, sexual, endocrine, and metabolic side effects associated with dopamine-blocking antipsychotics. The addition of Evenamide, which acts by attenuating glutamate release, to patients showing a worsening of their symptoms while on their current atypical antipsychotic, was not only well-tolerated, but showed a consistent pattern of benefit on all efficacy measures assessed. These preliminary results warrant further investigation in larger and longer trials in patients with more severe symptoms.”