Implantable Device for Heroin, Painkiller Addiction Closer to Approval

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An FDA panel of medical experts on Tuesday recommended the agency approve an experimental implant designed to treat patients recovering from heroin and painkiller addiction.

The matchstick-size implant, called Probuphine, slowly releases, over six months, a low dose of the drug buprenorphine, a common treatment for addicts that works by binding to opioid receptors in the brain but without producing the usual strong feelings of euphoria. 

Currently buprenorphine is available as a pill or film placed daily under the tongue, where it dissolves. The problem with that approach, says The New York Times:

In controlled doses, buprenorphine can help the body withdraw from opioid addiction, but can also itself be addictive. That risk is increased by the fact that the medicine can be taken only by mouth, requiring patients, often ill from addiction, to manage their daily dosages.

Emergency department visits involving buprenorhine numbered 30,135 in 2010, a whopping 1,000 percent increase over 2005, according to a 2013 report from the Substance Abuse and Mental Health Services Administration, a federal agency.

Probuphine is intended to cut down on such incidents by providing a safer and more reliable regimen than a self-administered approach.

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The FDA already rejected the drug-oozing device once before, after an advisory panel recommended it but raised questions about inadequate dosage levels and the company's physician training program, according to Bloomberg.

Braeburn Pharmaceuticals, which makes Probuphine along with Titan Pharmaceuticals, said patients who receive prescriptions will be required to see providers trained in implanting medical devices,  or undergo implantation and removal training themselves, USA Today reports.

Some panelists questioned whether Braeburn's studies accurately predict Probuphine's success in treating patients with long-term drug addiction, but the committee voted 12-5 for a positive recommendation.

More on what the FDA panelists said about Probuphine at MedPage Today.

Associated Press contributed to this report.

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