Can an Implant Stop Heroin Addiction?

Heroin and other opioids are devastating America. One major stumbling block to a solution has been keeping treatment consistent—and that fix may have just been found.

Four toothpick-­sized implants that deliver a steady dose of buprenorphine into the upper arm may be the future of drug treatment—could they end America’s heroin problem too? […]

Probuphine, an implant that delivers six months of steady buprenorphine, may be the answer the drug treatment world has been looking for. Understanding the implant begins with understanding its active component, buprenorphine. Synthesized in 1969, the drug first gained approval for opioid dependence in 2002—the first drug to gain approval under the Drug Addiction Treatment Act.

When the drug was first released, many hoped it would usher in the end of a growing opioid epidemic. With more people addicted to opioids than ever before, and 46 people dying from overdoses each day, it’s safe to say the plan has yet to work. […]

The downfalls of an oral form of buprenorphine was one of the central themes of the FDA hearing on probuphine on Jan. 12 of this year. The main clinical study presented in the hearing was a single, double­blind, active­controlled trial in which half of the 176 patients were given a real probuphine implant. Among those with implant, 88 percent tested negative for the presence of illicit opioids (compared to 72 percent in the control). […]

Not everyone in the room supported the decision. Dr. Tracy Rupp, director of Public Health Policy Initiatives at the National Center for Health Research, spoke out against it at the hearing. Rupp was concerned about missing urine samples, which she says were counted as negative, and said the all­ white study participants weren’t representative of the demographic. Plus, she worried, the drug could take weeks to reach stable levels—putting patients at risk of relapse. Others in the hearing voiced concerns that patients might tear it out of their arms.

More than two months later, her concerns around the safety of the drug remain.

“The probuphine implant was studied in only 87 patients for 6 months,” Rupp wrote to The Daily Beast. “This is not a large enough study to get a good understanding of the risks posed by this new form of treatment, nor is it of sufficient duration to understand the risks involved in placing a new implant every 6 months, in some cases for years.”

In the final conclusion of her testimony, Rupp told the advisory committee at the FDA that she was “disappointed to conclude” that the evidence wasn’t enough for her to endorse the drug. “While we all desperately want new treatments for opioid abuse, we have to be sure they are safe and effective,” she said. […]

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