PLYMOUTH MEETING, Pa., Sept. 18, 2018 /PRNewswire/ -- Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional (HCP) administration.
The study met its primary efficacy endpoint of Average Pain Intensity (API), demonstrating that patients with CLBP receiving treatment with CAM2038 experienced statistically significant reduction in pain compared with placebo (p < 0.001, mITT, effect size 1.03). Furthermore, the key secondary endpoint of Worst Pain Intensity also demonstrated statistical significance (p < 0.001, mITT, effect size 1.11).
"Patients with chronic pain previously treated with opioids for an extended period of time may not have adequate pain relief and are in need of alternatives," said Mike Derkacz, President and CEO of Braeburn. "If approved, CAM2038 offers an HCP-administered dosing regimen that will allow patients to transition from daily oral opioids to manage chronic pain, while potentially minimizing the risks of abuse, misuse and diversion."
The safety profile observed with CAM2038 was favorable and consistent with previous studies with CAM2038 as well as the known safety profile of buprenorphine. The long-term safety of CAM2038 is being evaluated in a 52-week open label extension study, in which patients are either continuing from the randomized efficacy portion of the study or were enrolled directly in the open label extension study phase.
"There are a large number of patients with CLBP who have not attained adequate relief of their symptoms on existing opioid therapy," said Richard Malamut, MD, Chief Medical Officer of Braeburn. "The results of this study suggest that CAM2038 may provide a safe and effective option for patients on chronic daily opioid treatment who are unable to reach an effective therapeutic dose as a result of poor tolerability and the development of tolerance."
About the HS-16-555 Phase 3 Efficacy and Safety Study
The Phase 3 study was a multi-center, double-blind, enriched enrollment, randomized withdrawal, placebo-controlled, safety and efficacy study of CAM2038 weekly and monthly versus placebo in patients with moderate-to-severe CLBP who required continuous around-the-clock opioid treatment ≥ 40 mg morphine equivalent dose. Patients who achieved a stable and effective dose of CAM2038 during the open label titration phase were randomized into a 12-week, double-blind treatment phase in which they were maintained on their current dose of CAM2038 or placebo. The primary efficacy endpoint of the study was the change in API from baseline to week 12 where pain was measured using an 11-point pain intensity numerical rating scale.
CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment of moderate-to-severe opioid use disorder and moderate-to-severe chronic pain. Buprenorphine is a partial-agonist at the mu opioid receptor and also exhibits antagonistic effects at the kappa opioid receptor. The product is designed for flexible and individualized treatment for both OUD and pain, providing sustained buprenorphine release in once weekly and once monthly formulations. Administration by healthcare professionals helps to ensure delivery and medication adherence, while potentially minimizing risks of diversion, misuse, and accidental pediatric exposure.
CAM2038 is currently under U.S. Food and Drug Administration (FDA) review for the treatment of moderate-to-severe opioid use disorder and is to be used as a part of a comprehensive treatment plan to include counseling and psychosocial support. In November 2017, the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 17-3 for recommending approval of CAM2038. The Advisory Committee's recommendation was based on a review of results from the CAM2038 clinical trial program that included seven Phase 1-3 clinical trials, five of which were in patients with OUD, including a pivotal Phase 3 efficacy and Phase 3 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 reactions.
CAM2038 will be supplied as ready-for-use prefilled syringes for weekly or monthly administration by a healthcare professional.
Braeburn is 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.