June 18, 2023

FDA Approves New Drug for Opioid Overdose Reversal

The FDA approved Opvee (nalmefene hydrochloride) nasal spray for the emergency treatment of known or suspected opioid overdose. This is the first FDA approval of nalmefene hydrochloride nasal spray for health care and community use.

Nalmefene is an opioid receptor antagonist which is used to treat acute opioid overdose. If nalmefene is administered quickly, it can reverse the effects of opioid overdose, including respiratory depression, sedation, and low blood pressure.

The newly approved product, which delivers 2.7 milligrams (mg) of nalmefene into the nasal cavity, is available by prescription and is intended for use in health care and community settings.

The use of nalmefene hydrochloride in patients who are opioid-dependent may result in opioid withdrawal characterized by body aches, diarrhea, fast heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

Opioid pain medications are commonly seen in workers’ comp claims, and even when used appropriately, opioids present certain safety risks, including risk of overdose. It is common for providers to co-prescribe opioid overdose reversal agents with certain opioid prescriptions as a pre-emptive action against potential overdose. Historically, this has included naloxone products, which also reverse opioid overdose, but with this approval there is now a new option available to patients.

The presence of this new medication means it may soon appear within workers’ comp claims.

Common adverse reactions to nalmefene hydrochloride include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion and throat irritation, pain in the nose, decreased appetite, skin redness, and excessive sweating.

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