FDA approves six month implant for treatment of opioid dependence

Posted on: May 31st, 2016 by sobrietyresources No Comments


May 26, 2016

The National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the first long-acting, subdermal buprenorphine implant for the treatment of opioid dependence. The medicated rods, implanted in a single procedure, are designed to provide an ongoing release of a low dosage of buprenorphine over the span of six months. The implant technology is approved for a specific subset of patients who are already clinically stable for at least six months on other approved buprenorphine delivery systems, including moderate doses of buprenorphine tablets or films.

Buprenorphine is a medicine currently approved to treat opioid use disorder and is available as a buccal tablet or a film placed under the tongue or against the inside of the cheek, both requiring self-administration by patients on a daily basis. The newly approved implantable form of buprenorphine, called Probuphine, is placed under the skin in the upper arm in an out-patient setting, and removed in a similar manner at the end of the treatment period. Other medications for opioid use disorder include methadone and naltrexone.

Medication-assisted treatment (MAT) is cost-effective and has been proven to help patients recover from opioid use disorder, reduce fatal overdoses, improve social functioning, reduce criminal activity, and lessen the risk of transmitting infectious diseases like HIV and Hepatitis C.

Yet, of the 2.2 million Americans 12 years of age or older who abused or were dependent on opioids in 2014, fewer than 1 million received MAT. Also, less than half of private-sector treatment programs have adopted MAT, and even in programs that offer MAT, only 34.4 percent of patients are prescribed them.

Probuphine is made and sold by Braeburn Pharmaceuticals who licensed the North American commercialization rights from Titan Pharmaceuticals. NIDA provided funding for early clinical trials to test the safety and efficacy of the drug for the treatment of opioid use disorder. Information about the availability of Probuphine will be made available on the Braeburn Pharmaceuticals website.

https://www.drugabuse.gov/news-events/news-releases/2016/05/fda-approves-six-month-implant-treatment-opioid-dependence

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