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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 Scientific Session
Date:5/8/2008

TAMPA, Fla., May 8 /PRNewswire-FirstCall/ -- Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today announced results from clinical trials that showed ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) capsules demonstrated clinically relevant features addressing abuse liability alongside a promising safety and efficacy profile. The Phase I and II studies, presented at the 27th Annual Scientific Session of the American Pain Society, examined the effects of ALO-01 when crushed -- a common method of abuse -- among recreational drug users and when taken whole, as intended, by chronic pain patients.

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 combines an extended-release opioid, morphine sulfate, with a sequestered core of naltrexone, an opioid antagonist, which is designed to be released if the capsule is tampered with by crushing, chewing or dissolving, thereby significantly reducing the euphoric effect of the opioid.

According to Phase I study findings, recreational drug users found crushed ALO-01 to be significantly less desirable than an equivalent dose of immediate release morphine sulfate solution and no more desirable than ALO-01 taken whole. Although study participants had five times higher levels of morphine in their blood after taking crushed ALO-01 (versus intact ALO-01), they reported significantly reduced drug liking, feeling high and good effects, including euphoria, compared to immediate release morphine sulfate solution.

Data presented from a separate Phase II study in
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SOURCE Alpharma Pharmaceuticals
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