What is the role of long-acting buprenorphine subdermal implant (Probuphine) in prevention of opioid abuse relapse?

Updated: Jun 21, 2018
  • Author: David W Dixon, DO; Chief Editor: Glen L Xiong, MD  more...
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Answer

A long-acting buprenorphine subdermal implant (Probuphine) was approved by the FDA in May 2016 for use in opioid tolerant patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphine-containing product (ie, doses ≤8 mg/day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent). Four implants (80 mg/implant of buprenorphine HCl) are inserted in the upper arm for 6 months of treatment and removed by the end of the sixth month. In addition to improved adherence, other benefits of buprenorphine implant include a reduced risk of diversion, abuse, misuse, and accidental exposure.

Efficacy of noninferiority was assessed for buprenorphine implant in clinically-stable patients on maintenance treatment by comparing the implant with daily doses of buprenorphine/naloxone SL of 8 mg or less. Results of primary and secondary endpoint analyses showed buprenorphine implant met the criteria for noninferiority with a 95% CI of (0.009, 0.167). [54]


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