Opioid use disorder: buprenorphine subcutaneous depot yields high retention rate

  • Frost M & al.
  • Addiction
  • 23.04.2019

  • von Kelli Whitlock Burton
  • Clinical Essentials
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Takeaway

  • Weekly or monthly extended release subcutaneous (SQ) buprenorphine depot (CAM2038) was effective at treating opioid use disorder (OUD), with a more than 70% 48-week retention rate, mostly mild to moderate treatment-related adverse events (AEs), and a safety profile similar to that of sublingual buprenorphine (SL BPN).

Why this matters

  • Although daily SL BPN is effective at treating moderate or severe OUD, there are reportedly high rates of nonadherence, diversion and misuse of medication, and accidental pediatric exposure.

Study design

  • Multicenter, phase 3, 48-week study.
  • 227 adult participants with OUD received CAM2038 weekly (8, 16, 24, or 32 mg) or monthly (64, 96, 128, or 160 mg) with flexible dosing and individualized titration.
  • Funding: Braeburn Inc.

Key results

  • 63.0% of participants experienced ≥1 treatment-emergent AEs (TEAEs), of which 56.4% had mild to moderate TEAEs.
    • Most common were pain, swelling, or erythema at the injection site; nasopharyngitis; headache; nausea; urinary tract infection; and vomiting.  
  • TEAE-related discontinuation rate was 2.2%.
  • 26.4% of participants had drug-related toxicities.
  • 82.8% of participants completed 24 weeks and 73.6% completed 48 weeks of treatment.
  • At the end of treatment, 82.8% participants converted from SL BPN and 63.0% new-to-treatment participants had negative urine samples for illicit opioids.

Limitations

  • Open-label, observational design.

Coauthored with Antara Ghosh, PhD