Clinical Trial of CAM2038, Long-acting Subcutaneous Buprenorphine Injections for Treatment of Patients With Opioid Dependence
Summary
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
Timeline
- Start
- 2015-12
- Primary completion
- 2016-10
- Completion
- 2016-11
Outcome
Met primary endpoint
paper a 3.0% difference (95% CI, -4.0% to 9.9%; P < .001). PMID 29799968 ↗
paper Compared with SL buprenorphine, depot buprenorphine did not result in an inferior likelihood of being a responder PMID 29799968 ↗
release “In the Phase 3 study enrolling 428 patients with opioid use disorder, CAM2038 achieved the main objective of statistical non-inferiority” camurus.com ↗
release “CAM2038, for treatment of opioid dependence, clearly fulfilled efficacy primary endpoints” camurus.com ↗
release “CAM2038 is also being studied for opioid use disorder and met the primary endpoint in a pivotal Phase 3 study” braeburnrx.com ↗
release “Head-to-head, Phase 3 study of weekly and monthly buprenorphine depots (CAM2038) vs standard treatment with daily sublingual buprenorphine/naloxone.CAM2038 met the primary endpoint of non-inferiority” camurus.com ↗
release “The results from the pivotal Phase 3 efficacy and safety trial demonstrate that BRIXADI met the primary endpoint of non-inferiority for responder rate” braeburnrx.com ↗
release “The pivotal Phase 3 efficacy and safety trial demonstrated that Brixadi met the primary endpoint of non-inferiority for responder rate (p<0.001)” camurus.com ↗
release “pivotal Phase 3 efficacy and safety trial, weekly and monthly BRIXADI met the primary endpoint of non-inferiority for responder rate versus daily SL BPN/NX” braeburnrx.com ↗
Publications
- Peterson S, Nunes EV, Lofwall MR, Walsh SL, Tiberg F. Exploring Opioid Use Disorder Outcomes by Quantitative Urinalysis: Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. J Addict Med. 2025 May-Jun 01;19(3):260-267. doi: 10.1097/ADM.0000000000001405. Epub 2024 Dec 4.
- Nunes EV, Comer SD, Lofwall MR, Walsh SL, Peterson S, Tiberg F, Hjelmstrom P, Budilovsky-Kelley NR. Extended-Release Injection vs Sublingual Buprenorphine for Opioid Use Disorder With Fentanyl Use: A Post Hoc Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2417377. doi: 10.1001/jamanetworkopen.2024.17377.
- Lofwall MR, Walsh SL, Nunes EV, Bailey GL, Sigmon SC, Kampman KM, Frost M, Tiberg F, Linden M, Sheldon B, Oosman S, Peterson S, Chen M, Kim S. Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2018 Jun 1;178(6):764-773. doi: 10.1001/jamainternmed.2018.1052.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Buprenorphine | Other / unclassified | 8 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 16 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 24 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 32 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 64 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 96 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 128 mg | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | 160 mg | Subcutaneous |
| Subject | Naloxone | Small molecule | 2 mg | Other |
| Subject | Naloxone | Small molecule | 8 mg | Other |