- 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.
- 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.
- 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.
- Open-label, observational design.
Coauthored with Antara Ghosh, PhD