The FDA approved Probuphine (Titan/Braeburn), the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
Until now, buprenorphine for the treatment of opioid dependence was only approved as a pill or film placed under the tongue or on the inside of a person’s cheek until it dissolved. While effective, a pill or film may be lost, forgotten or stolen. However, as an implant, the drug provides a new treatment option for individuals in recovery who may value the unique benefits of a six-month implant compared with other forms of buprenorphine, such as the possibility of improved patient convenience from not needing to take medication every day.
“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 aimed at reducing prescription opioid and heroin-related overdose, death and dependence.
Instead of opioid dependence or addiction, newer diagnostic terminology uses the term “opioid use disorder,” which includes both milder forms of problematic opioid use as well as addiction.
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 for death from all causes in half.
Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support. The drug consists of four, 1-inch–long rods that are implanted under the skin on the inside of the upper arm and provides treatment for six months. Administering the drug requires specific training because it must be surgically inserted and removed. Only a health care provider who has completed the training and becomes certified through the Probuphine Risk Evaluation and Mitigation Strategy (REMS) program should insert and remove the implants. If further treatment is needed, new implants may be inserted in the opposite arm for one additional course of treatment. The FDA is requiring postmarketing studies to establish the safety and feasibility of placing the implants for additional courses of treatment.
Safety and efficacy 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. A response to MAT was measured by urine screening and self-reporting of illicit opioid use during the six-month treatment period. Sixty-three percent of the buprenorphine-treated patients had no evidence of illicit opioid use throughout the six months of treatment—similar to the 64% of those who responded to sublingual buprenorphine alone.
The most common side effects from treatment include implant-site pain, itching and redness, as well as headache, depression, constipation, nausea, vomiting, back pain, toothache and oropharyngeal pain. Safety and efficacy have not been established in children or adolescents younger than 16 years of age. Clinical studies of buprenorphine did not include participants over the age of 65.
The drug has a boxed warning about insertion and removal being associated with the risk for implant migration, protrusion, expulsion and nerve damage resulting from the procedure. Buprenorphine must be prescribed and dispensed according to the REMS program because of the risks for surgical complications and accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin. As part of this program, buprenorphine can only be prescribed and dispensed by health care providers who are certified with the REMS program and have completed live training, among other requirements.
Buprenorphine implants contain a significant amount of drug that can potentially be expelled or removed, resulting in the potential for accidental exposure or intentional misuse and abuse if the implant comes out of the skin. Patients should be seen during the first week after insertion, and a visit schedule of no less than once monthly is recommended for continued counseling and psychosocial support.
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