Med Check: Opvee for Reversing Opioid Overdose, Brixadi, and More

The Food and Drug Administration (FDA) has approved Opvee (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose in patients 12 years of age and older, the agency announced in May. Opvee delivers 2.7 mg of nalmefene into the nasal cavity, is available by prescription, and is intended for use in health care and community settings.

Opvee was approved based on several studies. A confirmatory pharmacokinetic study comparing a 3 mg spray of the drug with a 1 mg intramuscular nalmefene hydrochloride injection in 68 healthy patients revealed that nasal nalmefene achieved higher plasma concentrations compared with the intramuscular injection.

A second study that found similar plasma concentrations of nalmefene whether the treatment was administered as a single dose in each nostril or as two doses in a single nostril. A third study found that the drug is noninferior to intranasal naloxone and that nasal nalmefene produced a greater reversal of remifentanil-induced respiratory depression that was nearly twice that produced by nasal naloxone at five minutes.

The FDA granted approval of Opvee to Opiant Pharmaceuticals Inc., which was acquired by Indivior in March.

In May the FDA approved Braeburn’s Brixadi (buprenorphine) extended-release injection for subcutaneous use to treat moderate to severe opioid use disorder (OUD), the agency announced.

In a phase 3 trial, 428 adults with OUD were randomized to receive either Brixadi or daily sublingual buprenorphine/naloxone for 24 weeks. Patients in both groups had similar rates of weekly and monthly negative urine tests, suggesting that Brixadi is about as effective as sublingual buprenorphine/naloxone in treating OUD.

Brixadi is available in two formulations: a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients who are already being treated with buprenorphine.

Brixadi is approved in both weekly and monthly subcutaneous injectable formulations at varying doses, including lower doses that may be appropriate for those who do not tolerate higher doses of extended-release buprenorphine that are currently available. The weekly doses are 8 mg, 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, and 128 mg.

Brixadi will be available through a Risk Evaluation and Mitigation Strategy (REMS) program and administered only by health care providers in a health care setting.

The FDA in May issued a Drug Safety Communication regarding prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD) and other disorders.

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA wrote.

To that end, the FDA is requiring several changes to the prescribing information to state that patients should never share their prescription stimulants with anyone. The Boxed Warning information will describe the risks of misuse, abuse, addiction, and overdose consistently across all medicines in the class, which includes amphetamines such as Adderall and methylphenidate such as Ritalin and Concerta. The Boxed Warning also will advise health care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction. The FDA is also requiring updates to the existing patient Medication Guides for these medications to help educate patients and caregivers about these risks. ■