BRIDGEWATER, N.J., Sept. 9 /PRNewswire-FirstCall/ -- Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today announced results from its Phase III pivotal efficacy trial that showed ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo. Findings also showed that ALO-01 capsules were safe and well-tolerated. This study was presented in a poster session at the 19th Annual Clinical Meeting of the American Academy of Pain Management in Nashville.
ALO-01 is an investigational pharmacologic abuse-deterrent, extended-release opioid that Alpharma is developing for the treatment of moderate to severe chronic pain. Utilizing Alpharma's proprietary technology, ALO-01 capsules combine an extended-release opioid, morphine sulfate, with a sequestered core of naltrexone, an opioid antagonist. When ALO-01 capsules are taken as directed, the naltrexone passes through the body without clinically meaningful release or accumulation.
According to the study findings, patients who were taking ALO-01 capsules reported significantly more effective pain relief, as measured by mean change in the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from baseline to the 12-week endpoint of the study, compared to patients who were taking placebo. Additionally, 72.5 percent of patients reported taking ALO-01 experienced pain relief of at least 30 percent from baseline, compared to 57.8 percent patients given placebo.
"These results are very exciting as we believe they demonstrate that
ALO-01 has the potential to bring clear clinical ben
|SOURCE Alpharma Inc.|
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