May 27, 2016 | By Nadia Sheikh

FDA Approves New Implant for Opioid Dependence

Addiction & Recovery News

As of yesterday, the FDA has approved the first-ever implant for the maintenance treatment of opioid dependence. The implant is called Probuphine and it is designed to provide a constant, low-level dose of buprenorphine for six months. The implant is available by prescription only to patients already stabilized on low-to-moderate doses of medications with buprenorphine in them.

Eighty people or more fatally overdose on opioids every day in the United States. There are 2.8 million people estimated to have diagnosed opioid abuse disorder. About one quarter of those take buprenorphine.

FDA Commissioner Robert M. Califf, M.D. said, “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…Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Buprenorphine, found in Subutex (buprenorphine hydrochloride) and Suboxone (buprenorphine hydrochloride and naloxone hydrochlrodie), is a partial opioid antagonist that is meant to suppress withdrawal symptoms, reduce cravings, and block the effects of opioids. It has been used in the treatment of opioid dependence as a pill, and as a film that is placed in the mouth until dissolved. But, with the innovation of an implant, there is no chance of a patient losing or forgetting to take their dose.

The implant consists of four, one-inch-long rods that are inserted under the skin on the inside of the upper arm. The Probuphine must be surgically inserted and removed by a health care provider who has completed the training, but the procedure only takes about 15 minutes. The FDA is monitoring all Probuphine implants and requiring post-marketing studies to assess the safety and feasibility of using the implants as a part of addiction treatment.

Along with counseling and behavioral therapy, medication can be an important part of a comprehensive treatment plan. Currently, methadone, buprenorphine, and naltrexone are the approved medications available. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), medication-assisted treatment cuts a patient’s risk of death from all causes in half.

Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health said, “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.”

The expansion of medication-assisted treatment options is a big part of the U.S. Department of Health and Human Services’ Opioid Initiative, working to reduce opioid and heroin related overdoses, deaths, and dependence. We understand the concept of dependence as “addiction,” yet the Department of Health is trying to draw an important distinction. “Opioid use disorder” is the new terminology describing milder forms of problematic opioid use, as well as addiction.

In clinical trials with opioid dependent adults, Probuphine implants demonstrated their safety and usefulness. As measured by urine screenings and self-reporting, 63% of the patients treated had no evidence of illicit opioid use throughout the six months of treatment. The success rate was nearly identical to patients who received doses of buprenorphine under the tongue.

The implant was developed by Titan Pharmaceuticals and is licensed to Braeburn Pharmaceuticals for sale in North America. It’s reported to be priced around $1,000 and $1,500 per month—more expensive than oral forms of buprenorphine, but more convenient, consistent, and likely to be used safely. The pricing is not specific yet, but there are plans for insurance rebate programs and payment assistance programs for patients.

The Probuhine implants have just been approved, yet they are a promising alternative for opioid dependents who are using medication to assist their treatment program.