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Home » ALPHARMA ANNOUNCES RESULTS FROM STUDY OF ABUSE-DETERRENT OPIOID
ALPHARMA ANNOUNCES RESULTS FROM STUDY OF ABUSE-DETERRENT OPIOID
October 2, 2006
Alpharma has announced positive results from a Phase II multidose clinical efficacy and pharmacokinetic trial for its abuse-deterrent, extended-release opioid. The goal of this study was to demonstrate that Alpharma's proprietary abuse-deterrent technology for long-acting opioids does not impact the safety or efficacy of the product. This goal was achieved, paving the way for an abuse-deterrent platform and multiple product opportunities.
Alpharma's proprietary technology combines an extended-release opioid with a sequestered core of the antagonist, naltrexone, in a single dosage form. If the product is taken as directed, it is intended that the naltrexone will remain sequestered and the patient will achieve pain relief similar to Kadian (morphine sulfate extended-release) capsules. If the capsule is tampered with by crushing, chewing or dissolving, it is expected that the naltrexone will be released and euphoria will be abated.
The Phase II multidose, multicenter, double-blind, crossover study evaluated patients with chronic moderate to severe pain due to osteoarthritis of the hip or knee who either required opioid treatment for joint pain or failed on non-opioid analgesics such as non-steroidal anti-inflammatory drugs or COX-II inhibitors. The trial showed no clinical or statistical differences between Alpharma's abuse-deterrent extended-release opioid and Kadian in pain scores of patients with chronic moderate to severe pain. Adequate sequestering of the naltrexone component was achieved. Furthermore, targeted morphine plasma levels for the new abuse-deterrent formulation were demonstrated.
KEYWORDS Drug Pipeline Alert
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