Braeburn Pharmaceuticals and Camurus has announced positive results from a Phase 2 pharmacokinetic study of weekly and monthly buprenorphine (CAM2038) depots in opioid dependent patients with moderate-to-severe non-cancer chronic pain.
A total of 65 participants were enrolled and received one of three doses of CAM2038 after being transitioned from sublingual buprenorphine.
The primary study objective was to characterize steady-state pharmacokinetic (PK) profiles after repeated dosing of CAM2038, including subcutaneous (SC) injections into four different injection sites. Other outcomes were safety and local tolerability, as well as measures of pain and opioid withdrawal symptoms. The PK results confirmed the target weekly and monthly dosing intervals for the CAM2038 depots, showing extended buprenorphine release with dose dependent steady-state through concentrations in the 2 to 3 ng/mL range.
Both pain and opioid withdrawal scores continued to be well controlled after transitioning from sublingual buprenorphine total daily doses of 24 mg and above. As in previous clinical studies, CAM2038 was shown to be well tolerated. Except for mild-to-moderate injection site reactions observed in four patients (6.2%), the safety profile was consistent with that of daily transmucosal buprenorphine medications.
“The study results provide further support that the weekly and monthly buprenorphine depots, if approved, will be effective for the treatment of opioid dependence. In addition, the Phase 2 data are supportive of the ongoing pivotal Phase 3 study of the management of moderate-to-severe chronic pain,” said Fredrik Tiberg, President and CEO, Camurus. “This is an important step in our endeavor to provide patients with opioid dependence or chronic pain with safe and effective long-acting therapies, also designed to minimize the risks of diversion and misuse.”
Moderate-to-severe chronic pain is a serious condition that affects approximately 200 million1 adults in the U.S. and Europe. Chronic pain has a profound impact on the quality of life of affected patients and contributes substantially to lost productivity, and increased morbidity, mortality, disability, and burdens on the healthcare system. In the U.S. alone, chronic pain is estimated to cost the nation more than $560 – 635 billion annually2, exceeding the estimated costs of heart disease, cancer, or diabetes.
“There is a critical need for effective options for the millions of people who suffer with chronic pain, but are also at risk for developing opioid addiction,” said Mike Derkacz, President and CEO of Braeburn Pharmaceuticals. “On behalf of these patients, we are pleased that this Phase 2 study demonstrated that CAM2038 was effective in treating not only chronic pain, but also preventing withdrawal symptoms in this vulnerable population. We believe these results hold promise and may allow physicians to customize therapy based on individual patients’ treatment goals.”
“These Phase 2 study results indicate the feasibility of a long-acting buprenorphine as a potential safe and effective treatment of chronic pain without the need for oral pain medications multiple times per day,” said principal investigator Dr. Greg Sullivan, Medical Director at Parkway Medical Center in Birmingham, Alabama. “Availability of multiple doses of both weekly and monthly durations provides the additional opportunity of individualized therapy.”