The Food and Drug Administration approved a new weapon in the fight against opioid use disorder (OUD) at the end of November. Buprenorphine extended-release injection is a once-a-month injectable form of buprenorphine, a medication used in treating people with moderate to severe opioid addiction.
“Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety,” FDA Director Dr. Scott Gottlieb said in a statement.
Buprenorphine is one of the most effective ways of treating opioid dependence. It curbs the desire and cravings to use heroin or prescription painkillers.
Like methadone, it’s considered a replacement therapy, though patients can start taking the medication even before the detox.
Until now, buprenorphine, which goes by the brand name Suboxone®, was only available as a daily tablet or a small film that dissolved under the tongue.
A once-monthly injection, like buprenorphine extended-release, removes the burden and decision of taking the medication on a day-to-day basis. For many people, this will likely be a game-changer and put buprenorphine extended-release injection in line with Vivitrol®, a similar monthly injection that’s shown promise.
Buprenorphine extended-release injection Clinical Trial Studies
The manufacturer of buprenorphine extended-release injection, Indivior, a London-based pharmaceutical company, ran two clinical studies before approval that involved some of the following:
- Included more than 800 adults with moderate to severe opioid use disorder
- In each clinical trial, one group received buprenorphine extended-release injections every month while the other received a placebo
- The control group that received the medication reported fewer opioid relapses in a six-month period and passed more urine tests than the group that received just the placebo
“This could be the first-line [medication] for opioid addiction,” Dr. Andrew Kolodny, co-director of opioid policy research at Brandeis University, said in an interview. “It could open up opportunities for getting more patients buprenorphine.”
Advancing Treatment Options for Opioid Use Disorder
The opioid epidemic remains one of the most significant public health challenges in the United States, although recent data show encouraging signs of progress.
According to the most recent provisional data from the Centers for Disease Control and Prevention, approximately 87,000 Americans died from drug overdoses during the 12 months ending in September 2024, a nearly 24% decrease from the approximately 114,000 deaths recorded during the previous year.
Further CDC estimates released in 2025 indicate that overdose deaths continued to decline. Preliminary data suggest that approximately 80,000 overdose deaths occurred in 2024, representing the largest single-year decline ever recorded. Opioid-related deaths fell to about 55,000, down substantially from more than 83,000 in 2023. Despite this improvement, drug overdose remains a leading cause of death among Americans ages 18–44.
Experts attribute these improvements to several factors, including:
- Expanded access to naloxone, an overdose-reversal medication
- Greater availability of medications for opioid use disorder (MOUD), including buprenorphine
- Increased harm-reduction efforts
- Broader access to treatment services and recovery support programs
- Changes in the illicit drug supply, particularly involving fentanyl and its precursors
Nevertheless, fentanyl and other synthetic opioids continue to drive a large share of overdose deaths, and emerging substances such as carfentanil remain a serious concern for public health officials.
The FDA continues to emphasize the importance of evidence-based treatment for opioid use disorder. Currently, three medications are approved for OUD treatment: buprenorphine, methadone, and naltrexone. All three have been demonstrated to be safe and effective when used appropriately.
FDA-approved Brixadi®
Since the approval of monthly injectable buprenorphine in 2017, additional long-acting formulations have become available. In 2023, the FDA approved Brixadi®, which offers both weekly and monthly dosing options, expanding treatment choices for patients and clinicians.
As of 2025, long-acting injectable buprenorphine products such as Sublocade® and Brixadi® are increasingly viewed as important tools in addressing opioid use disorder because they reduce the need for daily medication adherence and help patients maintain consistent treatment. Recent FDA-approved label changes for Sublocade have also simplified treatment initiation and expanded administration options, potentially improving access to care.
While the nation has begun to see meaningful reductions in overdose deaths, opioid use disorder continues to affect millions of Americans. Expanding access to effective medications such as long-acting buprenorphine remains a critical component of sustaining progress and preventing future overdose deaths.
Related:
What is Medication Assisted Treatment Therapy?
Facts About Heroin Laced with Fentanyl
Tips for Overcoming Addiction Triggers and Cravings
