The FDA approved the first-of-its-kind device on Thursday, mirroring the Obama Administration priority order in October 2015 to make anti-addiction drugs more available to Americans.
The implant, called Probuphine, is expected to be available to patients by the end of June this year. Labels are already being printed up for the long-acting opioid addiction treatment device, and today, training began for doctors who want to learn how to insert the four matchstick-sized rods under the skin.
“Opioid abuse and addiction have taken a devastating toll on American families,” said Dr. Robert M. Califf, commissioner of the FDA, when the announcement was made Thursday. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives.”
The approval of Probuphrine “provides the first-ever implantable option” to help patients maintain treatment addiction, Califf said. Because the device is implanted, addicts won’t miss their daily dose, and won’t be able to sell their supply to recreational users or other addicts, say many advocates.
Probuphrine is just the latest weapon in our arsenal of anti-addiction drugs. We also have methadone, buprenorphine or naltrexone, all playing a role in decreasing opioid overdoses, deaths, and dependence from heroin and opioids such as hydrocodone and oxycodone. It is hoped that probuphrine will be the cornerstone in a new treatment regimen.
How does Probuphrine work?
Probuphrine is manufactured by San Francisco-based Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals based in Princeton, New Jersey. The device contains a drug called buprenorphine, usually supplied in pill form or as a mat that is placed under the tongue until it’s dissolved, usually in daily doses.
With the implanted device, you don’t have to worry about taking a medication every day, nor will you experience the nasty orange-flavor of the Suboxone mat every day. There is no worry about your medication being lost, stolen or sold, and if you should go to jail or rehab while the implant is working, there is no worry over missed doses.
There is one catch to the use of the implant. It is available to those addicts who have been on low-to-medium doses of buprenorphine for at least six months. This means that about 325,000 of the 1.3 million patients currently taking buprenorphine will be eligible for the implant.
Global News Canada is reporting that the FDA has taken heavy criticism for not acting faster to address the growing epidemic of opioid abuse and addiction in the U.S. Heroin and opioid painkillers resulted in 28,650 fatal overdoses in 2014, the highest number ever recorded.
Braeburn’s CEO Behshad Sheldon said 2,200 doctors have already signed up to take the training course required to administer Probuphine. The company is prepared to train an additional 4,000 or more doctors by the end of the year.
