Fighting opioid addiction with medical devices: FDA approves new implant

The FDA today cleared a new opioid-addiction fighting implant from Braeburn Pharmaceuticals, the 1st of its kind to win a nod from the federal watchdog.

The matchstick-sized Probuphine implant, developed by Titan Pharmaceuticals Inc and privately owned Braeburn Pharmaceuticals, is by design less susceptible to abuse or the illicit resale that plagues existing oral therapies.

“Patients and their doctors now have Probuphine as a new option for the 6-month treatment of opioid dependence. Opioid addiction is a chronic disease and should be treated the same way we treat other serious, chronic diseases – with evidence-based medicine. With 78 people in the U.S. dying each day from opioids, it’s important that patients have more treatments to choose from as no one option will work for everyone. Probuphine is the first of what we hope will be many new and innovative approaches to treating this disease. We are grateful to all of the patients, investigators and to NIDA for their help and dedication that has brought us to this point,” CEO Behshad Sheldon said in a press release.

Currently, opioid addiction is predominantly treated with one of 2 options: methadone and buprenorphine. Methadone is only dispensed at government-endorsed clinics in pill form, and while buprenorphine is available outside said clinics in pill or film form, both methods can be lost, forgotten, stolen or ignored.

The newly cleared Probuphine implant is designed to deliver a slow-release of buprenorphine continuously for up to 6 months, providing a low dose of 8 mg or less per day, Braeburn said.

The FDA cleared the slow-release implant for patients who are already stable on a low or moderate dose of oral buprenorphine, and indicated that the device should be used alongside counseling and other support systems.

“Probuphine represents a significant step forward in addressing the serious lack of new treatment options in the last 15 years. With strong support from the President and the Secretary of Health and Human Services this year to expand access to medication assisted treatment, addiction specialists like myself are more confident we will be able to get more patients the treatment they desperately need. Opioid dependence touches people from all walks of life, no matter their socioeconomic status, race or gender; the more we educate and innovate the better chance we have at reducing the prevalence of this terrible disease,” American Society of Addiction Medicine prez Dr. Kelly Clark said in prepared remarks.

Despite the backing from the FDA, some doctors are concerned that the implant may incentivize patients to rely solely on medication, and ignore the lifestyle changes they need to make.  The company will also likely face push-back from supporters of total-sobriety approaches at treating addiction.

Material from Reuters was used in this report.

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