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News
The FDA has flagged a potential safety signal for evenamide, an investigational drug for treatment-resistant schizophrenia, after four deaths were reported among trial participants compared to one in the placebo group. The agency cannot rule out a fatal heart rhythm mechanism. The U.S. clinical hold on the phase III trial remains in place, though enrollment continues internationally.
The FDA has raised safety concerns about evenamide, an experimental drug being developed by Newron Pharmaceuticals for treatment-resistant schizophrenia, after four deaths were reported among patients in clinical trials — compared to just one death in the placebo group. The agency flagged the possibility of a fatal arrhythmic mechanism, meaning an irregular heart rhythm could be a contributing factor, though this has not been definitively confirmed.
Of the four deaths, investigators deemed three unrelated to evenamide. The fourth was classified as "possibly related" after two autopsies failed to identify a clear cause of death. Newron noted that evenamide causes a small shortening of the QTc interval on ECGs — an unusual finding, since QTc prolongation is the more commonly recognized cardiac risk marker, and no established screening threshold exists for QTc shortening.
The U.S. arm of the phase III ENIGMA-TRS 2 trial remains on clinical hold, though no U.S. participants have actually been dosed with evenamide. Enrollment continues outside the U.S., and results from the ENIGMA-TRS 1 trial are expected early next year.
By the Numbers:
Why it matters: Treatment-resistant schizophrenia affects patients who don't respond to standard antipsychotics, leaving them with very limited options. Evenamide represented a promising new mechanism of action, making these safety signals a significant setback for a vulnerable patient population and for the drug's path to approval.
