Opvee FDA Approval History
Last updated by Judith Stewart, BPharm on May 22, 2023.
FDA Approved: Yes (First approved May 22, 2023)
Brand name: Opvee
Generic name: nalmefene hydrochloride
Dosage form: Nasal Spray
Company: Indivior Inc.
Treatment for: Opioid Overdose
Opvee (nalmefene hydrochloride) is a nasal spray formulation of the approved opioid antagonist nalmefene hydrochloride for use in the treatment of opioid overdose.
- Opvee is indicated for the emergency treatment of known or suspected overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.
Opvee nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. It is not a substitute for emergency medical care. - Nalmefene hydrochloride is an opioid antagonist first approved by the FDA for opioid overdose as an injection formulation in 1995 under the brand name Revex (now discontinued). Nalmefene hydrochloride is a 6-methylene analogue of naltrexone, a well established opioid antagonist approved in a number of single ingredient and combination formulations.
- Opvee works as an antagonist at 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 nose. Additional doses may be administered (using a new nasal spray with each dose) if the patient does not respond or responds and then relapses into respiratory depression, every 2 to 5 minutes until emergency medical assistance arrives.
- Warnings and precautions associated with Opvee include risk of recurrence of respiratory and CNS depression; limited efficacy with partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine; precipitation of severe opioid withdrawal; risk of adverse cardiovascular effects; and risk of opioid overdose from attempts to overcome the blockade.
- Common adverse reactions include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinalgia, decreased appetite, dysgeusia, erythema, and hyperhidrosis.
Development timeline for Opvee
Further information
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