The Food and Drug Administration (FDA) has approved Opvee® (nalmefene) nasal spray 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. The product is intended for immediate administration as emergency therapy in settings where opioids may be present.
Opvee contains nalmefene, an antagonist at opioid receptors. Nalmefene reverses the effects of natural and synthetic opioids, including respiratory depression, sedation, and hypotension.
The approval was supported by data from a pharmacokinetic (PK) study (ClinicalTrials.gov Identifier: NCT04759768) comparing Opvee to an intramuscular (IM) injection of nalmefene hydrochloride 1mg. Results showed that Opvee achieved significantly higher plasma concentrations compared with the IM injection (P <.0001). Maximum plasma concentrations were observed in approximately 15 minutes, with a plasma half-life of approximately 11 hours.
The application also included data from a second PK study (ClinicalTrials.gov Identifier: NCT05219669) comparing 3 dosing regimens of Opvee. Findings showed dose proportional plasma concentrations whether the treatment was administered as a single dose in each nostril or as 2 doses in a single nostril.
The effect of Opvee on remifentanil-induced respiratory depression was also evaluated in a pharmacodynamic study (ClinicalTrials.gov Identifier: NCT04828005) that included 61 opioid-experienced, non-dependent study participants. Following Opvee administration, the time to onset of reversal of respiratory depression was observed to be between 2.5 and 5 minutes. Full recovery of respiratory drive was noted between 5 and 15 minutes postdose.
The most common adverse reaction reported with Opvee include nasal discomfort, headache, nausea, dizziness, hot flush, vomiting, anxiety, fatigue, nasal congestion, throat irritation, rhinalgia, decreased appetite, dysgeusia, erythema, and hyperhidrosis.
Opvee is supplied in a ready-to-use, unit-dose nasal spray device that delivers 2.7mg of nalmefene (equivalent to 3mg of nalmefene HCl). Each carton contains 2 unit-dose nasal spray devices.
The recommended initial dose in adults and pediatric patients aged 12 years and older is 1 spray delivered by intranasal administration, which delivers 2.7 mg of nalmefene. If the desired response is not obtained after 2 to 5 minutes, an additional dose may be administered using a new nasal spray device.
The need for repeat doses depends upon the amount, type, and route of administration of the opioid being antagonized. If there is still no response and additional doses are available, additional doses of Opvee may be administered every 2 to 5 minutes using a new nasal spray device with each dose until emergency medical assistance arrives; Opvee is not a substitute for emergency medical care.
Commenting on the approval, FDA Commissioner Robert M. Califf, MD, said, “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.”
Opvee is expected to be available in the fourth quarter of 2023.
- Indivior announces US Food and Drug Administration approval of Opvee® (nalmefene) nasal spray, an opioid overdose rescue medicine for natural and synthetic opioids like fentanyl. News release. Indivior. May 22, 2023. Accessed May 23, 2023. https://www.prnewswire.com/news-releases/indivior-announces-us-food-and-drug-administration-approval-of-opvee-nalmefene-nasal-spray-an-opioid-overdose-rescue-medicine-for-natural-and-synthetic-opioids-like-fentanyl-301831447.html,
- FDA approves prescription nasal spray to reverse opioid overdose. News release. US Food and Drug Administration. May 22, 2023. Accessed May 23, 2023. https://www.prnewswire.com/news-releases/fda-approves-prescription-nasal-spray-to-reverse-opioid-overdose-301831379.html,
- Opvee. Package insert. Indivior; 2023. Accessed May 23, 2023. https://www.indivior.com/admin/resources/dam/id/1179/NalmefeneNasalSpray_PI.pdf?inline=true,