Evenamide effective as adjunctive schizophrenia treatment

Newron Pharmaceuticals recently presented data that indicated efficacy of Evenamide, a sodium channel blocker, as an adjunctive treatment for schizophrenia.

“Evenamide uniquely combines voltage-gated sodium channel blockade with attenuation of glutamate release,” Ravi Anand, MD, chief medical officer of Newron, said in a press release. “The results of this first study in patients with schizophrenia confirm preclinical data, which indicated that Evenamide might provide significant evidence of efficacy as an add-on to the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia, without effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics.”

To assess tolerability, safety and preliminary efficacy of Evenamide as an adjunctive treatment for schizophrenia, researchers conducted a 4-week, phase 2a, randomized, double-blind, placebo-controlled study among 89 individuals with DSM-5 schizophrenia. Study participants had a mean baseline Positive and Negative Syndrome Scale (PANSS) total score of 62.9, mean illness duration of approximately 18 years, and were experiencing breakthrough psychotic symptoms while on stable and adequate doses of risperidone or aripiprazole. Participants were randomly assigned to receive 15 mg to 25 mg of Evenamide or placebo twice daily in addition to their current antipsychotic.

Mean change in PANSS total scores from baseline to day 28 was greater among participants who received Evenamide vs. those who received placebo (–5.1 vs. –3.7).

PANSS subscale scores statistically significantly improved from baseline to day 28 (14.8 to –1.28) among participants who received Evenamide.

The Evenamide group exhibited greater improvement in functioning and illness severity, compared with their standard antipsychotic alone.

A greater proportion of participants who received Evenamide exhibited improvement in overall condition, compared with those who received placebo (54% vs. 36%).

At day 28, the proportion of participants who exhibited improvement in PANSS positive subscale scores was significantly greater for the Evenamide group (74.5% vs. 43.6%; P = .0043).

Evenamide was well-tolerated, according to researchers. The most common adverse events were somnolence, insomnia, overdose, dry mouth, headache and cold sweat/hyperhidrosis.

Two participants in the Evenamide group discontinued treatment due to adverse events, including seizure and atrial fibrillation.

“The patients in this study, who were showing signs of worsening symptoms of psychosis while on doses of antipsychotics they had responded to in the recent past, benefited on all efficacy measures evaluated,” Anand said in the release. “The onset of improvement occurred early in treatment. Evenamide was not associated with any increase in extrapyramidal, sexual, endocrine, cardiac, laboratory or metabolic side effects caused by the use of antipsychotics. The addition of Evenamide 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.”