PLYMOUTH MEETING, Pa., May 14, 2018 /PRNewswire/ --Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and safety of CAM2038, an investigational buprenorphine weekly and monthly subcutaneous injection for the treatment of adults with moderate-to-severe opioid use disorder (OUD), have been published online in the Journal of the American Medical Association (JAMA) Internal Medicine. In this study, CAM2038 met the primary endpoint of non-inferiority versus daily sublingual buprenorphine/naloxone (current Standard of Care) and demonstrated superiority for the key secondary endpoint.
"Publication of the Phase 3 study results in JAMA Internal Medicine further validates the potential clinical benefit of CAM2038 for patients with OUD to improve treatment outcomes," said Mike Derkacz, President and CEO of Braeburn. "We are honored to have the results for our weekly and monthly subcutaneous buprenorphine depot injection published in JAMAInternal Medicine and address a significant patient need."
The Phase 3 study was designed to reflect real-world application and enrolled 428 patients with OUD, including those with concomitant use of other substances of abuse at baseline. CAM2038 achieved primary endpoint of statistical non-inferiority compared to the active comparator of daily sublingual buprenorphine/naloxone (SL BPN/NX) for the pre-specified endpoint of responder rate (RR) (CI -4.0%, 9.9%; p<0.001).
Importantly, the secondary endpoint (Cumulative Distribution Function of the mean percentage of opioid-negative samples confirmed by self-report) demonstrated statistically superior treatment effect (p=0.004). The overall safety profiles were comparable between the two treatment groups, with few serious adverse events reported for the CAM2038 and SL BPN/NX (3.2% vs 6.0%, respectively).
"The flexible dosing options of CAM2038 reflect the real-world treatment needs of patients with OUD and enable providers to best match the treatment to their patients," said Dr. Michelle Lofwall, Assoc. Professor of Behavioral Science and Psychiatry at the University of Kentucky Center on Drug and Alcohol Research and Primary Investigator in the study. "The flexibility to choose both the duration and dose of burpenorphine based on individual needs, while also administering directly to the patient, could improve treatment and reduce the risk of non-adherence that contributes to the stigma surrounding patients with this devastating illness."
CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for flexible and individualized treatment from initiation and stabilization to longer-term maintenance therapy, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by healthcare professionals ensures delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure. CAM2038 has been 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.
CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. If approved, CAM2038 will be offered in a range of dosage strengths for once weekly and once monthly subcutaneous injections.
Braeburn is a pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. The company's mission is to advance a portfolio of next-generation therapies, with individualized dosing regimens and delivery options, to address the escalating disease burden of addiction faced by patients, healthcare professionals, payers and society. For more information about Braeburn, please visit www.braeburnrx.com.