The U.S. Food and Drug Administration has told the developer of an experimental schizophrenia drug that four deaths among patients who took it could represent a safety signal involving fatal heart rhythm problems. The drug, evenamide, is being tested as an add-on treatment for people whose schizophrenia does not respond to standard medicines.
Italian drugmaker Newron Pharmaceuticals disclosed the FDA's concerns in a company statement issued Oct. 8. The FDA letter has not been made public, so the details come from Newron's summary. A clinical hold remains in place at U.S. sites in the company's ENIGMA-TRS 2 trial.
