Opioid use disorder (OUD) is a pattern of opioid use that becomes hard to control, even when it is causing problems in your life or putting your health at risk. It is a treatable, long-term medical condition — not a sign of personal failure. Medicine is one of the most effective tools available to help manage it.
One option for treating moderate-to-severe OUD is Brixadi (buprenorphine), an extended-release injection given just once weekly or monthly. Brixadi contains buprenorphine, the same active ingredient found in daily tablets and films that you place under your tongue (sublingual). But Brixadi delivers it in a long-acting form, so you do not have to use it daily.
The FDA first approved Brixadi in 2023. It is meant to be used alongside counseling and other psychosocial support, not as a standalone treatment.
Keep reading to learn how Brixadi works, who it is approved for, how it is given, and what studies have shown about its benefits. (You may also want to read about Brixadi side effects and interactions in the companion articles.)
How Does Brixadi Work for Opioid Use Disorder?
Buprenorphine, the medicine in Brixadi, is a partial opioid agonist. That means it attaches to the same receptors in the brain that opioids such as fentanyl, heroin, and oxycodone attach to, but it activates them only partway. This is different from a full opioid agonist, which fully activates those receptors.
Because buprenorphine only partly activates opioid receptors, it can:
- Ease cravings and withdrawal symptoms
- Reduce the "high" you feel from using other opioids because buprenorphine occupies the receptors and blocks other opioids from attaching as strongly
- Carry a lower risk of the dangerous breathing problems seen with full opioid agonists, at typical doses
Once injected, Brixadi changes from a liquid into a soft gel just under the skin. This gel slowly releases buprenorphine into your body over a week or a month, depending on the version you receive. This helps keep buprenorphine levels steady between doses, rather than the rise and fall that can happen with a daily pill.
How Is Brixadi Given?
Brixadi is only given by a health care provider as a shot just under the skin (subcutaneous) of the buttock, thigh, stomach area, or upper arm. You cannot use it at home or give it to yourself. This is required as part of the Brixadi Risk Evaluation and Mitigation Strategy (REMS) program. This safety program is built around the fact that injecting Brixadi into a vein instead of under the skin can cause serious harm or death. You can learn more about the Brixadi REMS program on this website.
There are two versions of Brixadi:
- Brixadi (weekly): Given every seven days
- Brixadi (monthly): Given every 28 days
If you are new to buprenorphine treatment, you will likely start with weekly Brixadi after tolerating a test dose of a sublingual buprenorphine product. If you are already established on a sublingual buprenorphine medicine, your health care provider may switch you directly to either the weekly or monthly version. Many people move to the monthly injection once they are stable on a consistent weekly dose.
Who Is Brixadi Approved For?
Brixadi is FDA-approved for adults with moderate-to-severe OUD who:
- Have already tolerated a single dose of a buprenorphine product that goes under the tongue (sublingual) or inside the cheek (buccal), or
- Are already taking a medicine that contains buprenorphine
Brixadi is not the right medicine for people who have never taken an opioid before (opioid-naive people). Brixadi is not recommended if you have moderate-to-severe liver problems. So, your health care provider will also consider things such as how well your liver works.
How Was Brixadi Studied?
The main study supporting Brixadi's approval was a 24-week study involving 428 adults with moderate-to-severe OUD. It compared Brixadi injections to daily sublingual buprenorphine/naloxone tablets. Participants who received Brixadi also took placebo tablets (containing no active medicine), while those who received the daily tablets received placebo injections. Neither the study participants nor the investigators knew which type of active buprenorphine participants were receiving.
At the start of the study, participants were, on average, in their late 30s. About 62% were male, about 75% were White, and 22% were Black or African American. Most had a history of using heroin (around 71%) or misusing prescription pain relievers (around 29%), and about half used opioids by injection.
For the first 12 weeks, participants received weekly injections (or matching sublingual tablets); for the next 12 weeks, they moved to monthly injections (or continued matching tablets). Everyone also received individual drug counseling throughout the study.
What Are the Benefits of Brixadi Based on Studies?
Researchers measured how many participants met a strict "responder" definition. This meant having a negative opioid test based on urine tests and self-reports at the end of each (weekly and monthly) treatment phase, and only rare positive tests in between.
About 17% of people on Brixadi met this responder definition, compared to about 14% of people on daily sublingual buprenorphine/naloxone. This showed that Brixadi worked at least as well as the daily tablets.
Researchers also looked at the percentage of drug tests that came back negative for illicit opioids over the course of the study. A higher percentage of people on Brixadi had opioid-negative test results across the 24-week study compared to people on daily tablets, but this difference was less pronounced among people who were already doing well on either treatment.
Your results may differ from those seen in clinical studies.
Does Brixadi Block Other Opioids?
A separate study looked specifically at whether Brixadi (weekly) blocks the effects of other opioids. In this study, 47 people with moderate or severe opioid dependence received two doses of Brixadi (weekly) at either 24 milligrams (mg) or 32 mg, then were given test doses of hydromorphone (an opioid) to see how much of a "drug-liking" effect they still felt.
Starting with the very first Brixadi injection, the drug-liking effects of the test opioid doses were blocked, and that blockade held steady through both weekly injections. This suggests Brixadi can help reduce the reward someone might otherwise feel from using another opioid while in treatment.
Your results may differ from what was seen in clinical studies.
Is There Cost Assistance Available for Brixadi?
If cost is a concern, ask your health care provider's office or pharmacy about copay savings support that may be available through the drugmaker for people with eligible insurance. You can also find more information on their website at www.brixadi.com/copay-and-savings or by calling Brixadi's support line at 833-274-9234 to ask about program details and whether you qualify.
