FDA flags four deaths in schizophrenia drug trial, keeps U.S. hold
The FDA told Newron Pharmaceuticals that four deaths among patients taking its experimental schizophrenia drug may signal a heart risk, the company said Thursday. The agency's freeze on U.S. enrollment in a key trial remains in place. One patient on a placebo also died, and Newron says it sees no pattern of heart trouble.
A U.S. freeze on a late-stage schizophrenia drug trial is staying in place, and now the public knows why.
Newron Pharmaceuticals, an Italian drug company, said Thursday that the FDA sent a letter explaining its hold on U.S. sites in a study of evenamide. The drug is meant for people with treatment-resistant schizophrenia, whose symptoms do not ease with current medicines.
The letter cites four deaths among patients who took evenamide across all of its studies, compared with one death among patients on a placebo. Study doctors judged three of the four deaths unrelated to the drug. The fourth was rated "possibly related" because two autopsies could not find a clear cause.
The FDA called the deaths a potential safety signal because a deadly heart rhythm problem cannot be ruled out after the fact, Newron said. Evenamide is a sodium channel blocker. Some drugs in that class can cause irregular heartbeats that lead to seizures or serious heart events, BioSpace reported.
Newron pushed back, saying more than 10,000 heart tests from about 700 patients show no pattern of heart problems. Chief Medical Officer Ravi Anand said the death rate was 0.56% on the drug and 0.27% on placebo. Adjusted for time on treatment, he said, the rate was lower on the drug. "Patient safety is our utmost priority," he said.
The hold began in April after a patient died at a trial site outside the United States, FDA Webview reported. The FDA reaffirmed it in September. No U.S. patient in the study has received the drug.
The company is pressing ahead with its larger global study, which expects to finish signing up at least 600 patients by mid-October, with first results due in early 2027. Newron is also weighing extra heart screening for trial patients before it answers the FDA.
What we know: The FDA cited four deaths on the drug and one on placebo, and the U.S. hold remains.
What we don't: When Newron will reply or whether the FDA will lift the hold.
Where outlets agree BioSpace and RTTNews both report four deaths among evenamide patients versus one on placebo, with three judged unrelated and one possibly related.
Where they differ The outlets cited here report the same key facts so far.