Braeburn Pharmaceuticals and Camurus have enrolled the first Phase 3 CAM2038 trial patients to assess the safety and effectiveness of CAM2038 in patients with lower back pain whose present course of treatment involves opioids.
“The Phase 3 trial is unique as it is the first time a subcutaneous long-acting depot has been investigated in a pivotal trial for treatment of chronic pain,” Camurus President and CEO Fredrik Tiberg said. “The trial will provide essential insights into the efficacy and safety of CAM2038 for treating a patient population that currently has few treatment choices."
The study represents an important expansion of Camurus' current development program for CAM2038.
“The effectiveness of opioids for pain, on one hand, and the potential for their misuse, on the other, has created a dilemma for medical professionals,” Braeburn President and CEO Behshad Sheldon said. “Patients in chronic pain require these medications. Doctors are walking a tightrope as they work to treat their patients suffering chronic pain at the time of a full-blown epidemic of opioid addiction, one of the most significant public health crises facing our nation. Our vision is to provide doctors with effective, long-acting alternatives to currently available pain medications.”