FDA flags potential safety signal for investigational schizophrenia drug

The FDA flagged a potential safety signal after four deaths were reported among people with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, Newron Pharmaceuticals said. The FDA also noted one death among participants who received placebo. Study investigators considered three of the four deaths unrelated to evenamide. One was considered possibly related because two autopsies did not identify a definitive cause, according to Newron.

Newron said the FDA's concern involves the possibility that sodium channel blockers could trigger arrhythmias leading to serious cardiovascular events or seizures. The company said a fatal arrhythmic mechanism could not be definitively ruled out after review.

The FDA's enrollment hold remains in place at U.S. study centers for the phase III ENIGMA-TRS 2 trial, while enrollment continues in other countries and additional sites are being added, Newron said. No U.S. participants have been dosed with evenamide. The company expects to announce results from the 12-week primary endpoint assessment of ENIGMA-TRS 1 early next year.