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Alpharma Presents Positive Pharmacokinetic Study Results of Its,Investigational Abuse-Deterrent, Extended-Release Opioid

orie, high-fat breakfast and took the study drug 30 minutes later. Blood samples for morphine pharmacokinetic analysis were drawn prior to dosing and at intervals from 0.5 to 168.0 hours post-dose.

The results of the pharmacokinetic analysis demonstrated, for both the fasted and fed states that the release characteristics of morphine were consistent with a sustained-release formulation and were similar to previous study results for KADIAN(R) (morphine sulfate extended-release) Capsules. Most naltrexone levels were below the assay measurement limits. Adverse events, reported in five subjects, were mild to moderate in intensity and resolved without treatment.

This study was conducted as part of Alpharma's medical development program for its abuse-deterrent morphine product, and its results were consistent with data generated in the Phase II clinical program for this product.. The company is targeting an NDA filing for its abuse-deterrent product in the first half of 2008.

Other Data Presented on KADIAN(R) Capsules

Also presented at the annual meeting were data that showed the extended- release properties of KADIAN(R) were maintained even in the presence of a significant quantity of alcohol. These results indicate that the concomitant use of tested levels of alcohol with KADIAN(R) has no significant impact on mean morphine blood levels or the timing of morphine release. Recently, the U.S. Food and Drug Administration completed a review of this data and concluded that the KADIAN(R) black box warning did not need to include any precautionary language related to alcohol.

About KADIAN(R) Capsules

KADIAN(R) capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate-to-severe pain, when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The capsules can be taken once-daily (q24h) or twice-daily (q12h), as prescribed, to provide up to 24 hours o
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