Pharmaceutical

FDA approves first buprenorphine implant to treat opioid addiction

Opioid abuse Shutterstock 315x210 FDA approves first buprenorphine implant to treat opioid addictionThe Food and Drug Administration (FDA) has approved the first implant to treat opioid addiction. Probuphine is designed to deliver a constant, low-level dose of the medication buprenorphine for six months to patients who are already stable on low-to-moderate doses of other forms of buprenorphine.

Buprenorphine is currently available as a treatment for opioid dependence as a pill or a film placed under the tongue or on the inside of a person’s cheek until it is dissolved. While effective, pills or films may be lost, forgotten or stolen. As an implant, Probuphine provides a new treatment option for people in recovery.

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, MD. “Today’s approval provides the first-ever implantable option to support patients’ efforts to maintain treatment as part of their overall recovery program.”

Expanding the use and availability of medication-assisted treatment (MAT) options like buprenorphine is an important component of the FDA’s opioid action plan and one of three top priorities for the U.S. Department of Health and Human Services’ Opioid Initiative aimed at reducing prescription opioid and heroin related overdose death and dependence.

MAT is a comprehensive approach that combines approved medications (currently, methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use, without causing the cycle of highs and lows associated with opioid misuse or abuse. At sufficient doses, it also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive.

According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for their opioid use disorder cut their risk of death from all causes in half.

The safety and efficacy of the Probupine implant were demonstrated in a randomized clinical trial of adults who met the clinical criteria for opioid dependence and were considered stable after prior buprenorphine treatment.

The most common side effects from treatment with Probuphine include implant-site pain, itching, and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. The medication also carries a black box warning that insertion and removal of the implant are associated with the risk of implant migration, protrusion, expulsion and nerve damage resulting from the procedure.

If the implant comes out or protrudes from the skin, there is a risk of surgical complications as well as accidental overdose, misuse and abuse. This also poses a risk of accidental exposure or intentional misuse and abuse.

Source: FDA