FDA Approves New Treatments for Opioid Overdose, Opioid Use Disorder

On Monday, the FDA approved Opvee (nalmefene hydrochloride; Indivior) as an emergency treatment to reverse known or suspected opioid overdose in people ages 12 years and older.

Opioid overdose continues to be a major public health crisis in the US. According to the CDC National Center for Health Statistics, more than 79,000 fatal overdoses were reported in the 12-month period ending in December 2022, 90% of which were linked to synthetic opioids like fentanyl.

Nalmefene will be available by prescription as a single-dose nasal spray device. It is expected to be on the market in the fourth quarter of the year under the brand name Opvee. It is intended for use by first responders, healthcare providers, as well as in the community. Nalmefene is a opioid receptor antagonist similar to naloxone (Narcan), which was recently approved to be sold as an over-the-counter (OTC) drug.

"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," FDA Commissioner Robert M. Califf, MD, said in a press release.

If nalmefene is administered promptly, it can reverse the effects of opioids, such as respiratory depression and excessive sedation. The newly product provides 2.7 milligrams (mg) of nalmefene into the nasal cavity.

Opvee was developed by Opiant Pharmaceuticals, which was recently acquired by Indivior. Pricing information is not yet available.

Studies of intranasal nalmefene demonstrate that the drug offers rapid reversal of opioid overdose similar to that of naloxone. In contrast, however, nalmefene’s effects are longer-lived, which may be especially beneficial for treating synthetic opioid overdoses.

New Buprenorphine Option Approved for Long-Term Treatment of Opioid Use Disorder

On Tuesday, the FDA approved Brixadi (buprenorphine extended-release injection; Camurus/Braeburn) to treat moderate to severe opioid use disorder (OUD) in patients who have already started treatment with a transmucosal form of buprenorphine. The drug will be available as a subcutaneous injection that is given once weekly or once monthly by a healthcare professional as part of a comprehensive treatment program.

About three million people in the US are diagnosed with OUD, also known as opioid dependence, but only about half are receiving medical treatment for it. The Consolidated Appropriations Act of 2023 removed the federal requirement for healthcare providers to apply for a special “X-Waiver” before prescribing medications, such as buprenorphine, for the treatment of OUD. The goal of this change is to encourage more providers to prescribe buprenorphine, thus increasing patient access to OUD treatment.

“A weekly and monthly buprenorphine injection with different dose options can align with clinical practice and patient care needs,” Dr. Michelle Lofwall, Professor at the University of Kentucky Center on Drug and Alcohol Research, stated in a press release.

“[Some patients] prefer not taking a daily medication or visiting a pharmacy to pick up their medication, so having a weekly and monthly option that provides buprenorphine over one week or one month could benefit patients, their loved ones, and the treatment providers,” she stated.

Braeburn anticipates that Brixadi will be available in the US starting in September 2023. The list price is not yet identified.

Brixadi’s labeling carries boxed warnings for serious risks, such as blood clots and tissue damage, that are associated with intravenous administration. As such, the drug will be available through a restricted program and must be administered by a qualified healthcare professional. As a Schedule III controlled substance, the medication also carries risks of addiction, abuse, and misuse, among other serious precautions.