Approval covers the treatment of known or suspected opioid overdose in adults and pediatric patients 12 years of age and older. This market the first such authorization for this type of spray in healthcare and community use.
The FDA nod comes on the heels of the March authorization of over-the-counter Narcan. Narcan (naloxone hydrochloride) rapidly reverses the effects of opioid overdose and remains the standard treatment for such an overdose. The nasal spray first received FDA approval in 2015 as a prescription drug.
“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 Dr. Robert M. 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.”
Indivior acquired Opiant Pharmaceuticals in March of this year. The FDA said it granted approval to Opiant, however.
About Opvee (nalmefene) from Opiant Pharmaceuticals
Namalefene, an opioid receptor antagonist, treats acute opioid overdose. If administered quickly, it can reverse the effects of opioid overdose. That includes respiratory depression, sedation and low blood pressure.
Opiant Pharmaceuticals’ Opvee delivers 2.7 mg of nalmefene into the nasal cavity. It’s available by prescription for use in healthcare and community settings.
According to an FDA news release, Opiant Pharmaceuticals supported this approval with safety and pharmacokinetic studies. It also conducted a study in people who use opioids recreationally to assess how quickly the drug works. Common adverse reactions include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose (rhinalgia), decreased appetite, skin redness (erythema) and excessive sweating (hyperhidrosis).
The FDA granted Opiant Pharmaceuticals a priority review designation. That expedites the development and review of drugs that can potentially provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition.
