US-based Braeburn Pharmaceuticals and Swedish biotechnology firm Camurus has begun enrolling for its Phase III trial of CAM2038 in patients with moderate-to-severe chronic low back pain who are currently being treated with opioids.
CAM2038 is a buprenorphine subcutaneous injection product with flexible dosing, developed for weekly and monthly administration to treat opioid addiction and pain.
The Phase III randomised, double-blind, placebo-controlled trial is based on an enriched-enrolment, randomised withdrawal (EERW) design that intends to determine the safety and efficacy of CAM2038 in treating moderate-to-severe chronic low back.
Study investigator and pain specialist Jeffrey Wayne said: "The study is evaluating long-acting depot formulations of buprenorphine in patients that despite treatment with high doses of daily opioid medications have received inadequate pain relief.
“In addition to potentially improving treatment outcomes for these patients, these innovative formulations should have a significant positive impact on the growing healthcare crisis of opioid abuse, overdoses and diversion."
The study will involve a total of 170 patients aged 18 to 75 in its open-label, dose titration period, followed by a randomised, double-blind, placebo-controlled 12-week treatment period.
During the first phase, patients will be treated with CAM2038 on a weekly basis until the pain is addressed.
Patients who achieve the desired effect will proceed to the next phase to be randomised on a 1:1 basis and treated with weekly or monthly analgesic doses of CAM2038 or placebo.
The study is primarily focused on achieving a baseline change in pain as determined by the change in a patient's weekly pain from baseline to the 12th week of the treatment phase.