Newron Pharmaceuticals recently announced that the US Food and Drug Administration (FDA) has placed a hold on the enrollment of new patients in the US sites of its phase 3 ENIGMA-TRS 2 study of evenamide, targeting the modulation of excessive release of glutamate in patients suffering from Treatment-Resistant Schizophrenia (TRS).

The FDA action follows Newron’s notification to the agency of the sudden death of a study participant at a clinical site outside the US. The investigator assessed the event as unrelated to study treatment.

The company has informed the independent international safety monitoring board for the overall ENIGMA-TRS program, which has reviewed the event and recommended that the studies continue as designed. ENIGMA-TRS 1, performed in 21 countries, continues with more than 400 patients having been enrolled. ENIGMA-TRS 2 has received regulatory approval in Argentina and India, and is in final stages of receiving approval in Colombia and Malaysia.

Newron is working closely with the FDA and intends to provide the requested information to support resolution of the hold and the resumption of enrollment at US sites for the ENIGMA-TRS 2 study.

Ravi Anand, Chief Medical Officer (CMO), Newron, said, “Patient safety remains our highest priority, all patients who enroll in the evenamide program are thoroughly evaluated. The ENIGMA-TRS program with evenamide is monitored by an independent international safety monitoring board. The board has been informed of the event and has concluded that the studies should continue as designed. In the evenamide development program, to date, there is no increase in the risk of mortality between evenamide and placebo-treated patients based on the duration of treatment. Sudden death unfortunately is not uncommon in patients with schizophrenia.”

Studies show that schizophrenia significantly increases mortality and reduces life expectancy by 10-25 years compared with the general population and sudden unexpected deaths are noted in at least 20 percent of these cases of mortality.