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FDA approves new drug to reverse opioid overdose

Opvee is approved for use on patients 12 years and older.
FDA approves new drug to reverse opioid overdose
Posted at 12:40 PM, May 23, 2023

A new nasal spray can reverse the effects of an opioid overdose. 

The Food and Drug Administration gave its stamp of approval to Opvee, which can be used on patients 12 years and older. 

The product delivers 2.7 milligrams of nalmefene, which stops an opioid overdose, to a person's nasal cavity, the FDA says. 

"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," said Mark Crossley, CEO of Indivior, the pharmaceutical company that created Opvee. 

SEE MORE: Narcan maker aims for over-the-counter price under $50

According to the Centers for Disease Control, more than 100,000 people in the U.S. died from an overdose in 2021. About 70,000 of those deaths were due to synthetic opioids, primarily fentanyl.

The FDA said it granted the application "priority review" because of its potential to have a "significant" impact on the opioid problem plaguing the country. 

"The agency continues to advance the FDA Overdose Prevention Framework and take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products,” said FDA Commissioner Robert M. Califf.

Unlike Narcan, another drug approved to reverse the effects of an opioid overdose, Opvee requires a prescription. 


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