Implant Tested in Miami to Treat Opiate Addiction Gains FDA Approval

When Carolina noticed the bus advertisements in 2011, she had already run out of hope. What had begun as a low dose of Percocet to manage back pain three years earlier had spiraled into a full-blown opioid addiction. The 30-year-old had lost her job. Relationships with her family were strained. Attempts to get off the drugs had resulted in torturous detox followed by relapse.

Desperate for a solution, she called the number on the ad. Shortly thereafter, Carolina — who requested New Times use only her first name due to privacy concerns — had a small matchstick-like implant inserted into her left armpit at Miami’s Segal Institute for Clinical Research.

For six months, the implant slowly released a drug called buprenorphine. By the end of the trial, she was completely off pills and had no desire to return. She has been clean since.

“I never thought I’d actually do a clinical trial,” she says, “but I’m so glad I did.”

Now, in the midst of a crippling national opioid epidemic, that innovative treatment will soon be available to others suffering from addiction to heroin and opioids. Last week, the U.S. Food and Drug Administration announced it had approved Probuphine, developed by the companies Braeburn Pharmaceuticals and Titan Pharmaceuticals.

Dr. Scott Segal, president and chief medical officer of the Segal Institute, which administered Carolina’s trial, says he thinks it will be widely available by this summer.

“Patients do very well on the implant,” Segal says. “It takes relapse off the table for six months, so it’s not a constant daily struggle anymore.”

Today an estimated 2.5 million Americans are addicted to opioids. Approximately 20 percent of them are addicted to illicit opiates, such as heroin, and the other 80 percent to prescription opioids, such as oxycodone, according to Braeburn. And opioids are some of the most difficult drugs to kick because of their debilitating withdrawal symptoms.

Buprenorphine, which was approved by the FDA in 2002, is used to treat opioid dependence but until last week was available only as a pill or a film placed in the mouth to dissolve. The implant, Probuphine, works by delivering a low-level dose of buprenorphine continuously for six months.

“While effective, a pill or film may be lost, forgotten, or stolen,” according to the FDA news release. “However, as an implant, Probuphine provides a new treatment option for people in recovery who may value the unique benefits of a six-month implant.”

Segal admits he was initially skeptical of the implant.

“I thought, No one is going to get such an invasive procedure,” Segal says. “But the first trial filled up rapidly, and the patients did very well, with no ill effects. By the time the next study rolled around, I had no hesitation.”

The Segal Institute administered the trial to some 100 patients, with exceptional success rates. Carolina says she began to see results immediately. Over the course of the six months, she visited Segal once a month for check-ins and physicals. “Every month, I was better and better,” she says. “I didn’t feel any symptoms.”

At the end of the six-month trial, Carolina made an appointment to have the implant removed. She’s been drug-free since. Now, five years later, in addition to working at a restaurant in Hollywood, she’s studying medicine.

Segal says that's the same situation he saw across the board. Many of the patients who participated came in on disability, unable to work or take care of their children. “All of a sudden, you watch them month-to-month get back to their family, start working, get their lives together,” he says.

After seeing so many patients break their addictions, he thinks Probuphine will be a “huge step forward” in the fight against opioid addiction.

“Our staff doesn’t always get to see people get better,” Segal adds. “But in this study, it was very clear. This is really the first time our studies made such a huge difference in people’s lives.”