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Alpharma Announces Positive Results From Pivotal Phase III Efficacy Trial on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) Capsules at the American Academy of Pain Management Annual Clinical Meeting
Date:9/9/2008

efit to pain patients while delivering peace of mind to physicians and pharmacists," said Joseph Stauffer, D.O., Chief Medical Officer, Senior Vice President of Clinical Research & Medical Affairs, Alpharma Pharmaceuticals. "We look forward to collaborating with the FDA during the review process for ALO-01, which, if approved, would be the first opioid medicine to provide a pharmacologic abuse-deterrent feature while effectively treating patients with chronic pain."

On September 2nd, Alpharma announced that the United States Food and Drug Administration ("FDA") had accepted its New Drug Application ("NDA") for ALO-01 capsules for priority review. The priority review status provides for a review period of six months from the date of submission. The ALO-01 capsule NDA was submitted on June 30, 2008.

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.(1A) Opioids provide effective pain management and are especially useful in treating appropriately selected patients with moderate to severe chronic pain who have not responded adequately to other pain management therapies.(2,3A) However, prescription opioid abuse has escalated along with increased legitimate use in pain management.(1B,4A,5) In fact, 70 percent of people who have abused opioids got them from friends and relatives (by stealing, buying, or receiving them).(6) Because of potential prescription opioid abuse, patients and physicians may be reluctant to initiate opioid therapy for pain relief.(4B) Therefore, there is a need for products that deliver effective pain relief while minimizing the potential for misuse, abuse and diversion.(3B,7)

Study Design

The 12-week, double-blind, randomized, placebo-controlled enriched enrollment Phase III pivotal trial assessed the effectiveness of ALO-01 capsules when compared with placebo in 344 adult patients with moderate to
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SOURCE Alpharma Inc.
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