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First Ever Buprenorphine Implant For the Maintenance Treatment of Opioid Dependence

On May 26, the US Food and Drug Administration (FDA) announced its approval of the first ever implant for the maintenance treatment of opiate addiction. Marketed by San-Francisco, CA-based Titan Pharmaceuticals and Princeton, NJ- based Braeburn Pharmaceuticals, the newly approved implant called Probuphine is designed to slowly release a low-level dose of buprenorphine continually for a period of 6 months. The implant is recommended for patients who are stable on low to moderate doses of buprenorphine administered either in sublingual tablet or film form ( two generic versions of the drug Suboxone approved by the FDA in early 2013) and is aimed at supporting their efforts to maintain treatment as part of their complete recovery from opioid addiction.

In the context of a nationwide opiate abuse epidemic that has taken an unprecedented toll on American families, expanding the availability and use of medication-assisted treatment options such as buprenorphine, considered to be a safer opioid addiction treatment option than methadone is a key component of the FDA's opiate action plan and the comprehensive federal efforts to reduce prescription opiate overdose, dependence and death. Medication-assisted treatment (MAT) combines FDA-approved medications i.e. buprenorphine, naltrexone or methadone, counseling as well as other behavioral therapies for the treatment of opiate use disorders. Adherence to MAT with the opioid agonist buprenorphine significantly reduces the debilitating symptoms associated with opiate withdrawal, blocks the craving for opioid narcotics and lowers the risk of death by 50%.

Dr. Scott Segal, chief medical officer and president of Segal Institute for Clinical Research in Miami believes that the newly approved buprenorphine implant Probuphine will be available across the nation by this summer. The Segal Institute administered the clinical trial to some 100 adult patients, with unexpected success rates. 30-year old Carolina was one of these patients who had the small buprenorphine implant surgically inserted into their armpits in 2011. The implant consists of four 1-inch long rods implanted subdermally on the inside of the upper arm. Probuphine should only be inserted and removed by a health care provider who has completed specific training and become certified through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program.

As Dr. Segal pointed out, the first study filled up extremely fast despite being an invasive procedure, and all the patients , who had to visit the Segal Institute once a month for physicals and check-ins did very well over the course of the 6 months. Carolina admits that she began to see results instantly and, at the end of the trial, she made an appointment at the Segal Institute to have the buprenorphine implant removed from her left armpit. Carolina has been clean for five years and currently studies medicine, in addition to managing to find a job at a restaurant in Hollywood.

According to Dr. Scott Segal, most patients who chose to participate in the clinical trial came in on disability assistance, unable to find a job to support their families. Dr. Segal added that after seeing so many patients achieve complete recovery from their opiate addiction and getting their lives together, he strongly believes that the innovative opioid dependence treatment option will be a huge step forward in the fight against the opiate abuse epidemic sweeping the nation.

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