Alpharma Inc. announced results from its Phase III pivotal efficacy trial that showed Embeda(TM)/ALO-01 capsules provided significant pain relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee compared to placebo.

Combining an extended-release formulation of an opioid, morphine sulfate, and a sequestered core of naltrexone, an opioid antagonist, Alpharma is developing ALO-01 for the treatment of moderate to severe chronic pain. The naltrexone in ALO-01 passes through the body without clinically meaningful release or accumulation when taken as directed. The company believes the results demonstrate the drug’s potential to provide clear clinical benefit to pain patients without the risk of opioid abuse.

According to the study findings, patients 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 taking placebo. The study was a 12-week, double-blind, randomized, placebo-controlled phase III pivotal trial in 344 adult patients.

Alpharma recently announced that the United States Food and Drug Administration (FDA) has accepted ALO-01 capsules for priority review. In the United States, pain is a serious, undertreated public health problem, with 19 percent of American adults reporting chronic pain and 34 percent reporting recurrent pain. The company believes the FDA review process for approval of ALO-01 will show it to be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain.

Findings also showed that ALO-01 capsules were safe and well-tolerated, with mostly mild to moderate adverse effects. This study was presented in a poster session at the 19th Annual Clinical Meeting of the American Academy of Pain Management in Nashville

Source: Alpharma, Inc.