FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose

The use of opioid medications is at an all-time low but there is a need to remain vigilant to ensure those patients in need of pain management are not deprived of treatment and are encouraged to obtain the optimum combination of medications and other proven alternative options.

As announced previously, the FDA continues to advance the formal FDA Overdose Prevention Framework and continues to take actionable steps that encourage harm reduction by supporting the development of novel overdose reversal products. One such product, Opvee (Nalmefene Hydrochloride), is designed for the emergency treatment of known or suspected overdose caused by natural or synthetic opioids in adults and pediatric patients ages 12 years or older, as manifested by respiratory and/or central nervous system depression.

Nalmefene Hydrochloride, available by prescription, is the first nasal spray version of this drug approved by the FDA for healthcare and community use. Opvee nasal spray is intended for immediate administration as an emergency treatment where opioids may be present. Opvee works as an antagonist at the opioid receptors to reverse the effects of natural and synthetic opioids, including respiratory depression, sedation, and hypotension.

Opvee nasal spray is administered as a single spray intranasally into the nose. If the patient does not respond or responds and then relapses into respiratory depression, additional doses may be administered every 2 to 5 minutes (using a new nasal spray with each dose) until emergency medical assistance arrives. Opvee has limited efficacy with partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine.

What does this mean for all Workers’ Compensation stakeholders who are involved in delivering the most appropriate care to injured workers and are dedicated to optimum recovery and restoration of their quality of life? These continued steps by the FDA in the form of new products designed to reverse the harmful effects of opioids have the potential to save lives where these drug overdoses are the primary cause.