FDA Approves Nasal Spray for Emergency Overdose Treatment

Opvee nasal spray addresses respiratory depression, sedation, and low blood pressure.

The U.S. Food and Drug Administration (FDA) has given its approval for Opvee—the first nasal spray containing nalmefene hydrochloride—to be used for the emergency treatment of opioid overdose in adults and pediatric patients aged 12 and older. This is the first FDA approval of nalmefene hydrochloride nasal spray for both healthcare and community use.

Nalmefene is an opioid receptor resistor that treats acute opioid overdose by quickly reversing its effects, like respiratory depression, sedation, and low blood pressure.

“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 Commissioner Califf. “On the heels of the FDA’s recent approval of the first over-the-counter opioid reversal agent, the availability of nalmefene nasal spray places a new prescription opioid reversal option in the hands of communities, harm reduction groups and emergency responders.”

The FDA granted Priority Review designation to the Opvee application, indicating its recognition of the drug’s potential to significantly enhance the safety or effectiveness of treatment for a serious condition.

As the Lord Leads, Pray with Us…

  • For Commissioner Califf as he oversees the review and authorization of medications and treatments.
  • For FDA officials as they evaluate data and assess the effectiveness of therapies and substances submitted for approval.

Sources: Food and Drug Administration


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