Pharmaceutical companies Braeburn and Camurus have reported positive top-line results from a pivotal Phase III trial of buprenorphine (CAM2038) to treat moderate-to-severe opioid use disorder.
CAM2038 are buprenorphine subcutaneously administered drugs being developed for the treatment of opioid addiction.
The multicentre, randomised, double blind, double dummy, active controlled Phase III study was intended to establish the superiority of CAM2038 over daily sublingual buprenorphine / naloxone (SL BPN/NX), which is the current standard of care for opioid addiction.
The study examined 428 patients with opioid use disorder.
Results suggested the study achieving its primary endpoint, which was to establish the non-inferiority of CAM2038 against the standard care, additionally demonstrating superiority for the key secondary endpoint.
CAM2038 demonstrated safety profile similar to that of the group receiving the current standard care.
Braeburn president and CEO Behshad Sheldon said: "We are pleased with these significant clinical trial results, which show that our CAM2038 injectable buprenorphine products, if approved, can provide effective new solutions for patients and physicians.
"Opioid addiction is an overwhelming public health epidemic. In the United States alone, there are 2.6 million patients diagnosed with opioid addiction, and approximately 30,000 people die every year from opioid overdoses.
“CAM2038 comes in both weekly and monthly formulations, each in a range of dosage strengths, in alignment with clinical practice of treating opioid addiction, where different patients have different and evolving needs as they progress from treatment initiation to stabilisation and eventually long-term maintenance.”
CAM2038 is currently undergoing two other ongoing clinical trials to treat opioid addiction.