Newsletter June 2023
Substance Use Disorder Providers and Operations
Dr. Trisha Thrush, PhD, LMSW
Director of SUD Services and Operations
NEW Medications Coming to Support Individuals with SUD!
New Opioid Overdose Reversal Nasal Spray Receives FDA Approval
The US Food and Drug Administration (FDA) has approved a new opioid overdose reversal nasal spray for patients at least 12 years of age. The medication, called Opvee, was developed by Opiant Pharmaceuticals, a global pharmaceutical company that was acquired by Indivior in March.
Opvee contains nalmefene, an opioid receptor antagonist that reverses remifentail-induced respiratory depression within 2.5 to 5 minutes, with full recovery of respiratory drive as early as 5 minutes after administration. The duration of action of nalmefene is as long as most opioids, including fentanyl. Opvee is the first nalmefene hydrochloride nasal spray to gain FDA approval for healthcare and community use.
Indivior said in a news release that Opvee is slated to be made available by prescription in the fourth quarter of 2023. (Addiction Professionals, 2023).
FDA Clears New Buprenorphine Option to Treat OUD
The FDA has also given its approval for Brixadi, a new extended-release injection for subcutaneous use to treat moderate-to-severe opioid use disorder (OUD).
The medication is available in 2 formulations: (1) a weekly injection for patients who have started treatment with a single dose of a transmucosal buprenorphine product; or (2) who are already being treated with buprenorphine and a monthly injection for patients already being treated with buprenorphine.
Brixadi is approved at varying doses for both its weekly and monthly formulations, with lower doses that the FDA says may be appropriate for patients who cannot tolerate higher doses of extended-release buprenorphine products currently available. Weekly doses of Brixadi are 8 mg, 16 mg, 24 mg, and 32 mg. Monthly doses are 64 mg, 96 mg, and 128 mg.
Brixadi will be available through a Risk Evaluation and Mitigation Strategy program and administered only by providers in a healthcare setting. (Addiction Professional, 2023).
For questions related to these evidence-based practices, or feedback on additional training opportunities, please contact Trisha Thrush at Trisha.Thrush@midstatehealthnetwork.org.