In the fentanyl era, good news is scarce — opioids kill more than 80,000 Americans a year. But a new injectable medication has left addiction medicine providers feeling downright hopeful.
The medication, Brixadi, is the second long-acting injectable form of buprenorphine to gain approval from the U.S. Food and Drug Administration (FDA) and to be offered at Ideal Option.
Like the first buprenorphine shot, Sublocade, Brixadi is available as a monthly injection, but it also comes in a weekly formulation.
“Long-lasting injectables are the future of opioid addiction treatment,” says Jason Hanby, PA-C, a provider at Ideal Option. “Brixadi is another tool to aid in recovery and seems extremely promising.”
All forms of buprenorphine, whether daily Suboxone strips or extended-release injectables, suppress withdrawal symptoms and opioid cravings, dramatically boosting a patient’s odds of recovery. However, compared to formulations that must be taken daily, injectable buprenorphine makes life considerably easier for patients to remain in recovery from opioid use disorder (OUD).
“Buprenorphine, itself, is a miraculous medication, but getting people to take it is the problem. Brixadi eliminates that huge concern,” says Brian Dawson, M.D., Chief Medical Officer of Ideal Option.
With oral buprenorphine, patients must remember to take it daily and set aside 20 minutes for the medication to dissolve under their tongue.
But with long-acting injectable buprenorphine, patients avoid the daily hassle. What’s more, the medication is kept onsite and injected by a healthcare provider or pharmacist, “so patients can’t be tempted to sell or divert the medication,” says Dr. Dawson.
Nor do they have to worry their medication will be stolen. Residents of sober-living houses are often given a lock box for their oral buprenorphine or offered safe storage by staff.
“Brixadi is a guarantee the patient will be protected,” says Dr. Dawson.
Long-acting injectable buprenorphine, which fades gradually over a week or month, takes the daily routine out of the equation. Patients can focus their time and energy on other aspects of recovery, such as counseling, group meetings, securing work or housing, and rebuilding frayed relationships.
Brixadi can be injected in the hip, thigh, abdomen, or upper arm. Like all buprenorphine formulations, the shots can cause nausea, headache, and constipation, though typically these side-effects are mild and manageable.
Because Brixadi enters and exits the body at a more gradual rate than oral buprenorphine, some patients feel less discomfort, or none at all, with injections.
Among them is Robert, an Ideal Option patient with over 5 years in recovery. “The shot is amazing —crazy amazing,” says Robert, 43, who lost custody of his children due to his addiction and lived on the streets for over a year before seeking treatment.
With a 20-year history of addiction to heroin and opioid pills, Robert needed a high dose of oral buprenorphine.
“Oral buprenorphine gave me mood swings, and I’d feel hot and cold, like I was withdrawing a little bit,” says Robert, who today has a job and an apartment. “I took it to get by, and it was a lot better than drugs, but Brixadi is a miracle. I feel totally stable.”
Brixadi comes in four different weekly doses and three different monthly doses, accommodating a wide range of patients. For patients who need high doses of buprenorphine, it’s easier to take than oral buprenorphine.
One particular bonus of Brixadi, providers report, is the option of a weekly injection.
Early in treatment, it’s important for patients to establish a bond with their provider, and that’s best maintained with weekly, rather than monthly, visits.
“Most of our patients have been treated poorly by the healthcare system,” says Jason Hanby. “Gaining that therapeutic alliance early on is essential for recovery. We want to show we care.”
Weekly visits also keep patients accountable and adhering to a routine. After about a month, some patients, depending on their progress, will switch to a monthly injection.
Brixadi is not just a boon for patients already in treatment; the weekly formulation also shows great promise for transitioning hospital overdose patients to outpatient clinics such as Ideal Option.
Currently, most patients who land in the emergency department (ED) for an opioid overdose never find their way to treatment.
Typically, they’re revived by Narcan and perhaps sent home with a couple days’ worth of oral buprenorphine and a referral for outpatient treatment. But most don’t follow through during the brief window before the oral buprenorphine wears off and intense cravings return. Before they know it, they’re using opioids again.
In fact, evidence shows that after an ED visit for an opioid overdose, over 5% of patients die within a year — many in the first month alone. But with sustained buprenorphine treatment, the post-overdose death rate drops by half.
Brixadi, offering a week’s reprieve from withdrawal, may be the missing link, a life-saving bridge between the hospital and outpatient treatment. During that week of relative stability, more patients can summon the wherewithal to visit a clinic.
“Brixadi can really reduce barriers to treatment,” says Dr. Dawson. “It’s a much better scenario than if patients are given oral buprenorphine at the hospital and 24 hours later, they feel miserable and are back on fentanyl.”
In hospital emergency departments that offer Brixadi, opioid overdose patients revived by Narcan first take oral buprenorphine. If, after an hour, they don’t experience precipitated withdrawal, they’re eligible for the shot.
Brixadi, approved by the FDA in 2023, is so new that few hospitals are offering it, but early results are encouraging.
In a paper on 800 hospital opioid-overdose patients treated with Brixadi, the Yale School of Medicine reported a “high level of enthusiasm” for the shot among clinicians and patients.
Among the positive findings: All but 4 patients avoided precipitated withdrawal, a particularly intense and unbearable form of withdrawal that is a common concern with treatment of fentanyl addiction. In fact, the Yale researchers reported that based on their experience, “the concerns over precipitated withdrawal with fentanyl use appear to be overstated.”
Yale researchers called Brixadi a “stabilizing force” and reported that many patients followed up on treatment. One patient who was incarcerated briefly after his ER visit “expressed gratitude for not facing withdrawal symptoms while in jail,” according to the paper.
Indeed, Brixadi holds great promise for incarcerated OUD patients and is much easier than oral buprenorphine to administer in a jail setting. Ideal Option has received a grant to administer Brixadi at an Oregon jail, a program that should provide useful data.
“Another great thing about Brixadi in jail is there is no risk for diversion to other inmates,” says Dr. Dawson. “That’s always a concern with oral buprenorphine in jail.”
Even if the Oregon jail program proves successful, widespread use of Brixadi in jails may be a long way off due to the medication’s only real downside: its high cost. Currently, an injection costs significantly more than the equivalent dose of oral buprenorphine.
Many insurers, both public and private, won’t cover Brixadi, though more plans are coming around and streamlining the approval process.
“If you’re an insurer, wouldn’t you rather have a guarantee that a patient is actually taking their medication and not misusing or selling it?” says Dr. Dawson.
Brixadi is likely to go mainstream at hospitals before it comes to jails, but even now, few hospitals offer the medication.
“I think it’s more a lack of experience than anything else,” Dr. Dawson says.
At Ideal Option locations nationwide, providers have been trained in the administration of Brixadi. Patients covered by insurance can access the medication after a short trial on oral buprenorphine, to make sure they aren’t allergic to buprenorphine.
“As long as you can tolerate a dose or two of oral buprenorphine, you can get the shot pretty much right away,” says Dr. Dawson.
As the Yale paper observes, the fentanyl crisis demands an “urgent need for treatment innovations.”
Brixadi may well be a game-changing innovation.
Says Dr. Dawson: “All of us in addiction medicine have always hoped injections would take over.”