The U.S. Food and Drug Administration recently announced FDA approval of a prescription drug implant to fight opioid addiction. Opioid addiction is a problem of epidemic proportions, from street drugs such as heroin and more commonly from prescription drugs. Greater use and availability of medication-assisted treatment (MAT) is a top priority of the U.S. federal government.
In its 2016 report, the American Society of Addiction Medicine stated, “Of the 21.5 million Americans 12 or older that had a substance use disorder in 2014, 1.9 million had a substance use disorder involving prescription pain relievers and 586,000 had a substance use disorder involving heroin.” So more than 3 times the number with prescription meds than with heroin.
The ratio is not the same with addiction related deaths, but the trend is the same. “Opioid addiction is driving this epidemic, with 18,893 overdose deaths related to prescription pain relievers, and 10,574 overdose deaths related to heroin in 2014.”
The implant drug approved, Probuphine, is the first buprenorphine implant for long-term maintenance treatment of opioid dependence. When in place, the implant provides a constant, low-level dose of buprenorphine for six months. It is used with patients who are already successful with low-to-moderate doses buprenorphine in other forms (pills or a film that dissolves under the tongue). The implant is not used alone but along with the other dosage in a complete program that includes psychosocial treatment and counseling. The improvement the implant brings to the treatment plan is that, unlike a pill, the implant can’t be forgotten, lost, stolen, or intentionally skipped.
In testing submitted to the FDA by Titan Pharmaceuticals Inc. and Braeburn Pharmaceuticals (the two companies that will be marketing Probuphine) the implant success rates were equivalent to the sublingual forms of buprenorphine.
The FDA enthusiastically but guardedly spoke about the Probuphine implant. “Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives,” said FDA Commissioner Robert M. Califf, M.D. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”