Indivior's Overdose-Reversal Nasal Spray Gets FDA Approval
23 Maio 2023 - 4:21AM
Dow Jones News
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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