FDA Approves Opioid Addiction Implant Probuphine

A new treatment option is available for people in recovery from opioid addiction. The U.S. Food and Drug Administration approved Probuphine, an implant which releases small doses of buprenorphine, on May 26.

The implant is for patients who have been stabilized and have taken low or moderate doses of other forms of buprenorphine. Before the device’s approval, buprenorphine was only available in pill form or as a film that is placed under the tongue or on the inside of the cheek.

Buprenorphine is a maintenance medication that reduces withdrawal symptoms, cravings and the risk of overdose in individuals recovering from opioid addiction. Therapists prescribe it alongside counseling and behavioral therapy to reduce relapse risk.

“Opioid abuse and addiction have taken a devastating toll on American families,” FDA Commissioner Dr. Robert Califf said in a press release. “We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives. Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Like many daily medications, the pill or film forms could be forgotten, lost or stolen. Probuphine was designed to be a more convenient treatment option.

The FDA declined to approve Probuphine in 2012 because the agency believed the dose released by the device was too low to help a large number of patients. However, pharmaceutical manufacturer Braeburn produced additional clinical data and resubmitted its application for approval in 2015.

The device is now approved for patients who have been stabilized and maintained on low or medium doses of buprenorphine for six months. An estimated 325,000 people currently meet that criterion, according to Braeburn.

In her blog on the National Institute on Drug Abuse’s website, NIDA Director Dr. Nora Volkow called Probuphine “a game-changer in fighting opioid dependence.”

“Scientific evidence suggests that maintenance treatment with these medications in the context of behavioral treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programs aimed at abstinence,” Volkow said. “This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

Physicians will have to complete a training program before being certified to surgically insert or remove Probuphine because of the complexity of the procedure. Training programs became available at the end of May, and Probuphine is expected to be available to patients by the end of June, according to National Public Radio.

The Wall Street Journal reported that the device is expected to cost less than $6,000 for a six-month supply, but Braeburn CEO Behshad Sheldon declined to provide more details.

Experts disagree about how effective the treatment will be and whether insurance providers will cover it. Some experts are concerned about the device’s efficacy because it only delivers 8 mg of buprenorphine once daily, but some physicians prescribe between 4 and 24mg, depending on the severity of cravings.

Braeburn announced that it would consider refunding insurers if Probuphine was ineffective for patients or offer rebates to patients paying for the treatment out of pocket, according to NPR.

The company is currently studying the safety of inserting implants in the same spot repeatedly. It’s also testing weekly and monthly buprenorphine injections that could be available in multiple doses.

Probuphine Safety, Efficacy, Side Effects and Warnings

Braeburn funded a clinical trial that indicated Probuphine was safe and effective for adults who met the clinical criteria for opioid addiction and were stabilized before beginning buprenorphine treatment.

Using urine tests and self-reporting data, the study found that 63 percent of patients treated with Probuphine did not use illicit opioids during six months of treatment. In comparison, 64 percent of patients using other forms of buprenorphine treatment did not use illicit opioids.

There is no data on the safety and efficacy of the device in children and adolescents younger than 16 or adults older than 65.

The most common side effects of Probuphine treatment include pain, itching and redness at the site of the implant.

Other side effects include:

  • Headache
  • Toothache
  • Throat pain
  • Back pain
  • Constipation
  • Nausea
  • Vomiting
  • Depression

The FDA required Braeburn to include a black-box warning on the device’s packaging to detail the risks of migration, protrusion, expulsion and nerve damage associated with the implantation and removal procedure. The agency also advised health care providers to follow up with patients one week after the procedure and at least once every month thereafter to provide continued support.

When used in combination with counseling, therapy and social support, many addiction experts believe Probuphine will be a valuable treatment option that helps patients recover from opioid addiction.