The US Food and Drug Administration (FDA) has paused a trial evaluating a drug for treatment-resistant schizophrenia (TRS) after the death of a participant. 

Evenamide, developed by biopharmaceutical company Newron Pharmaceuticals, was being evaluated in the Phase III ENIGMA-TRS 2 study, targeting the modulation of excessive release of glutamate in patients suffering from TRS. 

The FDA placed the enrolment of participants in US centres on hold after Newron reported the sudden death of a patient at a clinical site outside the US. However, the investigator assessed the event as unrelated to study treatment. 

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

The ENIGMA-TRS 1, performed in 21 countries, will continue with over 400 patients having been enrolled. ENIGMA-TRS 2 has also received regulatory approval in Argentina and India, where it is expected to continue, and is in final stages of receiving approval in Colombia and Malaysia. 

“Patient safety remains our highest priority, all patients who enrol in the evenamide programme are thoroughly evaluated,” said Ravi Anand, Newron’s Chief Medical Officer. 

“The ENIGMA-TRS programme 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 programme, 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.” 

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