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Research Summary

Buprenorphine and Buprenorphine/Naloxone Soluble Films for Opioid Dependence

In 2010, the Food and Drug Administration approved a soluble film formulation of sublingual buprenorphine/naloxone (B/N) for the treatment of opioid dependence. Researchers conducted a randomized controlled trial of buprenorphine soluble film and B/N soluble film in 39 active heroin users to determine their effectiveness for suppressing withdrawal symptoms during buprenorphine induction. Subjects were maintained on subcutaneous morphine for 8 days prior to randomization to standardize opioid dependence. During that time, they underwent a naloxone challenge to confirm they could exhibit measurable withdrawal symptoms. After randomization, subjects received 12 mg buprenorphine soluble film or 12 mg/3 mg B/N soluble film in 3 divided doses on day 1 followed by 16 mg buprenorphine soluble film or 16 mg/4 mg B/N soluble film on days 2–5.

  • Four subjects (2 in each group) dropped out after the first dose due to inadequate control of withdrawal symptoms.
  • The remaining subjects had significant decreases in Clinical Opioid Withdrawal Scale (COWS) scores on day 1 that were sustained through days 2–5.
  • No significant differences in COWS scores, pupil diameter changes, or withdrawal symptoms were found between groups.
  • One subject (group assignment not reported) experienced elevated liver enzymes >3 times the upper limit of normal over the 5-day course of treatment.

Comments:

In this study, both buprenorphine and B/N soluble film formulations reduced withdrawal symptoms during induction with no significant differences between groups. However, the study was sponsored by the maker of both tablet and film buprenorphine formulations, and no comparisons with induction onto tablet formulations were reported. Having another form of effective treatment for opioid dependence may increase accessibility, but marketing claims of patient preference, faster dissolve time, improved taste, child resistance, and portability of the soluble film over tablet form have not been confirmed in independent studies. Alexander Y. Walley, MD, MSc

Reference:

Strain EC, Harrison JA, Bigelow GE. Induction of opioid-dependent individuals onto buprenorphine and buprenorphine/ naloxone soluble-films. Clin Pharmacol Ther. 2011;89(3):443–449.

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