Braeburn Pharmaceuticals, an Apple Tree Partners company,  and  Swedish research-based pharmaceutical company, Camurus announced that the first patients have been dosed with CAM2038, weekly and monthly subcutaneous buprenorphine injections, in a pharmacokinetic study of opioid dependent patients with chronic pain.

The primary objective of this phase 2 study is to assess the steady state pharmacokinetics of buprenorphine after repeated doses in opioid dependent patients with chronic pain, including effects of injection into different subcutaneous sites. This study will also explore the effect of CAM2038 on chronic pain, along with evaluation of safety and tolerability.

“This marks the fourth clinical study that has been started in the last five months for CAM2038, including two phase 3 trials in opioid dependence. The ability to use CAM2038 in multiple injection sites would allow physicians the flexibility to personalize treatments,” said Behshad Sheldon, president and CEO, Braeburn Pharmaceuticals. “Our goal is to provide a suite of best-in-class long-acting treatment options tailored to the individual needs of patients suffering from opioid dependence and chronic pain.”

“Patients that suffer from chronic pain and are also opioid dependent are a difficult population to treat,” said the principal investigator Dr Greg Sullivan, medical director at Parkway Medical Center in Birmingham, Alabama. “By using a long acting buprenorphine injectable, these patients would no longer be required to take medication multiple times per day. Buprenorphine also guards against hyperanalgesia and opiate tolerance, both of which are problems with conventional opiates.”

“CAM2038 has the potential to offer effective and safe around-the-clock pain relief, without risks of abuse and diversion. The pharmacological properties of buprenorphine together with long-acting release from the FluidCrystal formulation could also decrease risks of respiratory depression and overdose mortality associated with current opioid pain treatments,” said Fredrik Tiberg, President and CEO, Camurus.

The investigational CAM2038 buprenorphine subcutaneous injection products for treatment of opioid addiction are being developed as once-weekly and once-monthly formulations, each with multiple doses, to cover all phases of treatment from initiation through maintenance.  The CAM2038 products are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion, abuse, misuse, and accidental exposure. The CAM2038 products have been evaluated in three Phase 1/2 clinical trials, which evaluated the safety and tolerability as well as pharmacokinetic and pharmacodynamic properties of the products in a total of 176 individuals (opioid-dependent patients and healthy volunteers under naltrexone blockage).

Braeburn Pharmaceuticals, an Apple Tree Partners company, is a pill-free pharmaceutical company delivering precision medicine in neuroscience.  

Camurus is a Swedish research-based pharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions.