The Food and Drug Administration (FDA) has granted approval to the nalmefene hydrochloride nasal spray used as emergency treatment for opioid overdose, known commercially as Opvee and similar to Narcan.
Opvee has been approved as a prescription opioid reversal agent but has not gained OTC sale approval.
Approval was announced on May 22 for the first nalmefene hydrochloride nasal spray marked for the emergency treatment of possible opioid overdose in patients 12 years of age and older, an FDA press release said. It is the first therapeutic of its kind to receive the blessing of the FDA, which is seen as a giant step for the FDA Overdose Prevention Framework.
“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,” Dr. Robert Califf, FDA Commissioner, said in the release. “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 noted in the release that opioid overdoses continue to pose a great health problem in the United States, with more than 103,000 fatal overdoes reported during the 12-month period that ended in November 2022. Opvee uses nalmefene, an opioid receptor antagonist that can be used to treat opioid overdose, and the approval was based on studies that demonstrated the safety and efficacy of the therapeutic.
Side effects of the drug can include headache, nausea, dizziness, nasal discomfort, nasal congestion, hot flush, vomiting, anxiety, throat irritation, nose pain, appetite reduction, skin irritation and excessive perspiration; the release said.
The Associated Press reported that the drug is similar to naloxone, and both work by blocking the opioid impact on the brain and thus restoring breathing patterns and blood pressure in individuals who have overdosed. The FDA had previously approved Opvee as an injection treatment in the mid-199s, but it was ultimately was pulled from shelves because of low sales.
