Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientif...(cluding patients withmoderate to severe ...),Health

Date:5/8/2008

cluding patients with moderate to severe chronic pain due to osteoarthritis showed that the efficacy and tolerability of ALO-01 was comparable to marketed extended-release morphine sulfate capsules (KADIAN(R) Capsules). Additionally, when ALO-01 was taken as directed, the sequestered naltrexone had no impact on either pain relief or tolerability.

"The undertreatment of chronic pain and the abuse of prescription opioids are both serious health problems that require urgent attention," said Joseph Stauffer, DO, Chief Medical Officer of Alpharma Pharmaceuticals. "As the data suggest, ALO-01 has the potential to address issues of abuse liability while effectively treating patients with chronic pain."

On April 21, Alpharma announced that it withdrew its New Drug Application (NDA) for ALO-01 and plans to resubmit a revised application in approximately two months. While the initial NDA submission qualified for a priority review, certain technical issues around data presentation prevented a complete evaluation by the U.S. Food and Drug Administration (FDA) within the six month time period permissible for a priority review. Alpharma expects to address the submission issues and re-qualify for priority review in its resubmission, and continues to anticipate a first quarter 2009 launch following approval.

Pain is a serious, undertreated public health problem in the United States, 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 being given them).(6) Because of
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SOURCE Alpharma Pharmaceuticals Copyright©2008 PR Newswire. All rights reserved

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