Indivior's Overdose-Reversal Nasal Spray Gets FDA Approval

By Elena Vardon

Indivior on Tuesday said the U.S. Food and Drug Administration has approved its nasal spray OPVEE for emergency treatment for opioid overdose.

The U.K. pharmaceutical company said the regulator's approval covers the its use in adults and pediatric patients older than 12 years.

It is based on data from a pharmacodynamic study that showed the treatment provides fast onset of reversal of respiratory depression induced by the synthetic opioid remifentanil, the group said.

The spray is expected to be in the market in the fourth quarter of 2023, it said.

"OPVEE's FDA approval represents a significant achievement in the development of new treatment options to address today's era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl," Chief Executive Mark Crossley said.

Write to Elena Vardon at elena.vardon@wsj.com

(END) Dow Jones Newswires

May 23, 2023 03:06 ET (07:06 GMT)

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