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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

severe pain due to osteoarthritis of the hip or knee. After a screening and washout period from previous treatments (less than or equal to 14 days), patients were administered two periods of treatment with study drugs. Patients were first titrated to effective pain management levels with ALO-01 capsules during open label titration, they were then randomized to double-blind treatment with either ALO-01 capsules or placebo for 12 weeks. Study participants were allowed to use acetaminophen as a rescue medication, up to 500 mg every six hours, as needed.

Efficacy assessments included pain intensity scores on the BPI, recorded in a subject diary and assessed at in-clinic visits.

Safety and tolerability included measurements by rates of self-reported adverse events and a measure of opioid withdrawal, an indication of naltrexone leakage from the capsules, called clinical opiate withdrawal scores (COWS). ALO-01 capsules were safe and well-tolerated in this study, with an overall safety profile consistent with that of other opioid products. COWS data suggest that naltrexone did not leak out of the capsules, and there was no increased risk of opioid withdrawal versus placebo. Adverse events were mostly mild to moderate. The most common adverse events during titration with ALO-01 were constipation (30.5 percent) and nausea (21.0 percent); during the 12-week maintenance phase the adverse events were diarrhea (12.3 percent and 12.1 percent) and nausea (11.7 percent and 7.5 percent) for ALO-01 and placebo groups, respectively.

Forward-Looking Statements

Statements made in this release include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements, including those relating to future financial expectations, involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Information on other important potential risks
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SOURCE Alpharma Inc.
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