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Buprenorphine implant comparable to sublingual maintenance treatment for opioid dependence
Use of buprenorphine implants compared with sublingual buprenorphine did not result in inferior response rates among adults with opioid dependence maintaining abstinence with a stable dose of sublingual buprenorphine.
“Medical treatment of opioid dependence decreases illicit opioid use at a greater rate compared with psychosocial intervention or placebo alone and reduces morbidity, mortality, and spread of infectious diseases. Because only three available medications — methadone, buprenorphine, and naltrexone — are approved for treatment of opioid dependence, innovation is needed,” Richard N. Rosenthal, MD, of Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote. “A 6-month buprenorphine implant may improve treatment adherence, improve rates of opioid abstinence, and reduce susceptibility to increasing public health concerns of abuse, diversion, and unintentional pediatric exposure.”
To compare efficacy of 6-month buprenorphine implants with daily sublingual buprenorphine for maintenance treatment for opioid dependence, researchers conducted an outpatient, randomized, active-controlled, 24-week, double-blind, double-dummy study at 21 U.S. sites. Study participants were prescribed daily sublingual buprenorphine for at least 6 months, were abstinent while taking 8 mg per day or less of buprenorphine for 90 days or more and were indicated as clinically stable by their clinician. Participants were randomly assigned to receive sublingual buprenorphine plus four placebo implants (n = 90) or sublingual placebo plus four 80-mg buprenorphine hydrochloride implants (n=87). The cohort had a mean age of 39 years.
Overall, 96.4% of the buprenorphine implant group and 87.6% of the sublingual buprenorphine group were responders.
Nora D. Volkow
Over 6 months, 85.7% of the buprenorphine implant group and 71.9% of the sublingual buprenorphine group maintained opioid abstinence (HR = 13.8; 95% CI, 0.018-0.258; P = .03).
Adverse events associated with the implant occurred in 23% of the buprenorphine implant group and 13.5% of the sublingual buprenorphine group.
Adverse events not associated with the implant occurred in 48.3% of the buprenorphine implant group and 52.8% of the sublingual buprenorphine group.
“The approval of this new buprenorphine implant formulation provides a unique new tool to address the complex, often chronic and relapsing opioid use disorders. This novel implant system may help buttress patients’ decision-making deficits that are a core component of the addiction by making these lifesaving medication adherence decisions far more infrequent,” Wilson M. Compton, MD, MPE, and Nora D. Volkow, MD, of the National Institute on Drug Abuse, wrote in an accompanying editorial. “However, buprenorphine implants are currently approved by the FDA for only up to 1 year of treatment for a subgroup of patients who have already achieved and sustained prolonged clinical stability while receiving low-to-moderate doses of oral transmucosal buprenorphine, a caveat clearly stated in the product label. Even so, this novel approach to delivering care may open up treatment for new, previously difficult- to-reach populations or for those in the criminal justice system.” – by Amanda Oldt
Disclosure: Rosenthal reports grants and nonfinancial support from Braeburn Pharmaceuticals during the conduct of the study. Compton reports stock ownership in Pfizer, General Electric, and 3M. Please see the full study for a list of all authors’ relevant financial disclosures.