Camurus has announced positive results from a recently completed Phase I/II trial of its subcutaneous FluidCrystal® opioid dependence drug CAM2038. The trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug CAM2038 in patients dependent on opioids. Patients were assigned to one of the four CAM2038 treatment dose groups, allocated in accordance with pre-determined dose ranges of their pre-study treatment with sublingual buprenorphine (Subutex®or Suboxone®).
CAM2038 was found to be well tolerated both systemically and locally at all doses tested in the trial and no safety concerns were identified in the safety population (n=41). The pharmacokinetics obtained for CAM2038 demonstrate dose proportional and dose linear extended release of buprenorphine over at least 7 days with a rapid onset followed by slowly declining therapeutic serum levels of buprenorphine. The pharmacodynamics assessment of subjective and clinical opiate withdrawal symptoms (SOWS and COWS) were well controlled for up to 10 days after single-dose injection of CAM2038. Notably, these extended effects were seen for a dose that corresponded to only between one and two daily doses of sublingual Subutex® or Suboxone®. This suggests a very significant dose sparing, improvement in bioavailability and ultimately less buprenorphine on the street and less risk of drug diversion. The observation that the dose ranges of pre-study sublingual buprenorphine (Subutex® and Suboxone® ) and CAM2038 were compatible in terms of treatment effect (SOWS, COWS and time to rescue) between treatment groups indicates a relatively straightforward transition of patients from current treatment with once-daily sublingual buprenorphine to treatment with once-weekly CAM2038.
“CAM2038 combines a proven effective medication for patients with opioid dependence, buprenorphine, with an administration form and effect duration that is well suited to the current treatment practice for this group of patients, considering timing of matching psychiatric interventions and compliance aspects”, says Prof. Dr. Christian Haasen, Principal Investigator for the trial and Professor of Psychiatry at the University of Hamburg. “In light of the results from the present study, I believe CAM2038 is a promising therapeutic candidate for the treatment of opiate dependence.”
Opioid dependence is a chronic, often relapsing, disorder that contributes to major health and social challenges. It is a growing problem world-wide with currently about 5 million individuals in Europe and the U.S. using illicit opioids, such as heroin, according to the World Health Organization. A further 2.0 million individuals are estimated to be addicted to prescription opioid medications in the U.S. alone. However, only about 20 percent of the total opioid dependent population is currently receiving pharmacological treatment.
Following discussions with regulatory agencies in Europe and the US, Camurus intends to continue the clinical development of CAM2038 and plans to start a pivotal clinical trial for product registration in 2012.
CAM2038 is a ready-to-use, buprenorphine FluidCrystal® injection depot developed for the treatment of opioid dependency by controlling or eliminating opiate craving and withdrawal symptoms, such as vomiting, sweating, stomach cramps, diarrhea, and muscle pain that increase the risk of relapse into misuse. In contrast to current treatments, including once-daily sublingual buprenorphine (Suboxone® and Subutex®) and methadone, CAM2038 is designed for less frequent (i.e. once-weekly) dosing. Delivery is in the form of a convenient, ready-to-use, small volume subcutaneous injection providing steady therapeutic plasma levels over time, at a significantly lower (5-10 times reduced) average daily maintenance dose in comparison to Subutex® and Suboxone®. The Camurus CAM2038 product also addresses the poor bioavailability, absence of dose proportionality, and variable plasma concentrations of sublingual buprenorphine, in addition to allowing much lower total treatment doses. Furthermore, the CAM2038 product is primarily intended as an office-based treatment, thereby reducing the issues of poor treatment compliance, misdirection and misuse, which are common for sublingual buprenorphine.
Camurus is a research-based pharmaceutical company developing innovative therapeutics for diseases with high unmet medical needs. The company’s current pipeline includes products for treatment of pain, opiate addiction, cancer and growth hormone disorders. Based on its technology leadership in drug-delivery, the company is also active in a number of development partnerships and research collaborations with pharmaceutical and biotech companies globally.
For further information, please contact:
Fredrik Tiberg, President & CEO
Tel: +46 66 286 46 92