CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for the treatment of moderate to severe opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for individualized treatment from initiation and stabilization to longer-term maintenance therapy.
CAM2038 provides a slow release of the drug over time, through a proprietary technology known as FluidCrystal®, and is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure.
CAM2038 has been successfully evaluated in seven Phase 1-3 clinical trials, including a pivotal Phase 3 efficacy and a long-term safety study. The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events.
Braeburn’s New Drug Application for our long-acting weekly and monthly buprenorphine formulations (CAM2038) is currently under review by the FDA. A priority review designation has previously been granted for this application. If approved, CAM2038 will be marketed in the U.S., under a licensing agreement with Camurus, in a range of dosage strengths for once weekly and once monthly subcutaneous injection.
Braeburn is also investigating CAM2038 in opioid tolerant patients with chronic pain as part of its ongoing pivotal Phase III program.
Learn more about the results of CAM2038’s clinical trials.
The next generation proprietary FluidCrystal® Injection Depot Technology used in the subcutaneous injection of CAM2038 includes a lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the lipid solution transforms into a crystalline gel, which encapsulates the active ingredient, allowing for a slow release of the drug over time.
The FluidCrystal® Injection Depot Technology offers advantages for the final product including small overall injection volume which, in turn, allows for the use of a thin 23-gauge needle. The product does not require refrigeration and therefore
may reduce potential storage concerns.