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FDA Approves Implant to Treat Opiate Addiction

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Probuphine, an implant designed to treat opiate addiction.

The Food and Drug Administration has approved a new drug to treat opiate addiction called Probuphine. Its manufacturer calls it a game-changer, because it’s an implant that releases medication over months. But some Maine physicians who treat those with opiate addiction are more skeptical about the drug’s potential promise.

A major benefit of Probuphine, says Behshad Sheldon, the CEO of company that manufactures it — Braeburn Pharmaceuticals — is that it simplifies the medication aspect of treating opiate addiction. Patients don’t have to remember to take a pill every day or worry about their medicine getting lost or stolen. They also don’t have to worry about temptation.

“We’re all flawed human beings, so there are occasions when people who have opioid addiction make poor choices and may decide to stop taking the medicine on a Thursday so they can go out on a Saturday,” she says. “With Probuphine, that choice wouldn’t exist anymore.”

Probuphine provides six months of constant blood levels of buprenorphine, a medication already on the market to treat opiate addiction. It’s intended for those who already take buprenorphine and are further along in their recovery.

Dr. Meredith Norris, a Kennebunk-based family physician who treats opiate addiction, says she’s encouraged to see this kind of innovation around medication-assisted treatment.

“I think that it is going to solve a number of problems in terms of, will create improvement of access,” she says.

Norris says Probuphine could mean that more physicians will offer medication-assisted treatment, since they won’t have to worry about monitoring patient pill counts and the possibility of diversion.

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  “The kind of weird consequence that may happen is that since there’s not going to be as much diversion, there won’t be people buying street Suboxone as much,” she says. “Which is kind of a mixed blessing, because many people who can’t get into treatment are buying street Suboxone as a way of maintaining their sobriety.”

Other providers like Brent Miller, the program director for the Discovery House in Bangor, say they need as many tools as they can get to treat opiate addiction. But he says he worries that as new medications are approved, providing access to other, important aspects of treatment are overlooked.

“While the medication is important, it is only part of it. And the long-term recovery is based on the actual process of counseling and behavior change that a person does,” he says.

Dr. Mark Publicker, who runs a Portland-based private practice in addiction medicine, says he’s concerned that Probuphine could diminish oversight of patients. That’s not ideal for patients, he says, or physicians.

“Reimbursement is a challenge. I’m bewildered and don’t know what the business plan would be for a practicing physician who would be able to see a patient otherwise monthly, would put in an implant and see the person back in six months,” he says.

Publicker has his eyes toward other medications in the pipeline that he says will be more helpful, including one that’s injectable and lasts a month. Sheldon says in addition to Probuphine, the company is developing buprenorphine medication that’s injectable in weekly and monthly doses.

“Between the suite of products, we think we can really make a dent in this disease and change how treatment is both perceived and given in this country,” she says.

Sheldon says the company is also developing outcome-based agreements so that if insurance companies don’t see a savings in treatments using Probuphine, they will be rebated the difference.