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FDA approves six month implant for treatment of opioid dependence

Announcement

May 26, 2016

ProbuphineCourtesy of Braeburn Pharmaceuticals

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.

Read FDA press release http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503719.htm.

To see NIDA Director Dr. Nora Volkow’s blog, go to: https://www.drugabuse.gov/about-nida/noras-blog/2016/05/probuphine-game-changer-in-fighting-opioid-dependence

Read Dr. Volkow’s 2014 The New England Journal of Medicine article titled: “Medication-Assisted Therapies — Tackling the Opioid-Overdose Epidemic”.

Read Principles of Drug Addiction Treatment: A Research-Based Guide (Third Edition) to learn more about incorporating medications, such as buprenorphine, into treatment. 

For more information, contact the NIDA press office at media@nida.nih.gov or 301-443-6245. Follow NIDA on Twitter and Facebook.

Contact:
NIDA Press Office
301-443-6245
media@nida.nih.gov

About the National Institute on Drug Abuse (NIDA): The National Institute on Drug Abuse (NIDA) is a component of the National Institutes of Health, U.S. Department of Health and Human Services. NIDA supports most of the world’s research on the health aspects of drug use and addiction. The Institute carries out a large variety of programs to inform policy, improve practice, and advance addiction science. Fact sheets on the health effects of drugs and information on NIDA research and other activities can be found at www.drugabuse.gov, which is now compatible with your smartphone, iPad or tablet. To order publications in English or Spanish, call NIDA’s DrugPubs research dissemination center at 1-877-NIDA-NIH or 240-645-0228 (TDD) or email requests to drugpubs@nida.nih.gov. Online ordering is available at drugpubs.drugabuse.gov. NIDA’s media guide can be found at www.drugabuse.gov/publications/media-guide/dear-journalist, and its easy-to-read website can be found at www.easyread.drugabuse.gov. You can follow NIDA on Twitter and Facebook.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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