Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals said this week that a late-stage trial of its injectable opioid dependence treatment was successful. CMAX shares surged 16% at the beginning of the week following the announcement.
The injectable buprenorphine therapy could be another treatment used to combat the growing opioid epidemic in the United States, which claimed the lives of more than 47,000 Americans in 2014, according to the Wall Street Journal. In that same year, 650,000 Americans received buprenorphine to treat opioid addiction.
The Phase III study enrolled 428 patients to evaluate the injectable formulation of buprenorphine with patients suffering from opioid use disorder. Results showed that the injection is superior to the current table formulation, according to the Journal. The trial saw few serious adverse events, with comparable safety profiles between the 2 treatment groups. A complete analysis of the study is expected to be released at a conference in April 2017 and the companies plan to submit for regulatory approval by mid-2017.
“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,” Braeburn president & CEO Behshad Sheldon said in prepared remarks. “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 stabilization and eventually long-term maintenance. We believe that our CAM2038 products, together with our recently approved Probuphine 6-month buprenorphine implant, have the potential to transform the treatment of opioid addiction.”
“The positive results of this pivotal head-to-head Phase 3 study represent an important breakthrough for our weekly and monthly CAM2038 products for treatment of opioid dependence, as well as confirmation of the strength and applicability of our proprietary FluidCrystal technologies and pipeline,” Camarus president & CEO Dr. Fredrik Tiberg added. “The results of this rigorous evaluation of CAM2038 compared to standard of care provide strong support for our upcoming market authorization applications. The demonstrated robust treatment effect of CAM2038 versus daily sublingual buprenorphine further underscores the potential to significantly improve treatment outcomes, in addition to avoiding the complications and risks associated with current daily medications.”