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www.fdanews.com/articles/90573-study-shows-alcohol-does-not-affect-alpharma-s-kadian

STUDY SHOWS ALCOHOL DOES NOT AFFECT ALPHARMA'S KADIAN

February 12, 2007

Alpharma has results of a Phase IV study of Kadian (morphine sulfate extended-release) that demonstrate the pharmacokinetics of the long-acting opioid are not significantly affected by the consumption of alcohol. Alpharma conducted the study in response to a request by the FDA to assess whether alcohol interferes with the extended-release mechanism of action in long-acting opioids.

"This study demonstrated that the extended-release properties of Kadian were maintained even in the presence of a significant quantity of alcohol," Joseph Stauffer, vice president of clinical research and medical affairs at Alpharma, said. "We believe this information is valuable for doctors in their assessment of Kadian, and we will continue to educate clinicians and patients about the appropriate use of Kadian for moderate-to-severe chronic pain. Like most medications, Kadian should not be taken with alcohol."

These results indicate that the concomitant use of tested levels of alcohol with Kadian has no significant impact on mean morphine blood levels or the timing of morphine release. The company has provided these data to the FDA, and any future labeling implications will be determined following the completion of its review.

In the open-label, single-dose, three-way-crossover, pharmacokinetic, drug-interaction study, 32 healthy adult male volunteers, 21 to 40 years of age, were randomized to receive 100 mg of Kadian with either 8 ounces of ethanol while fasting, 8 ounces of ethanol while fed or 8 ounces of water while fasting. After the three-way crossover, all subjects then received an immediate-release morphine formulation with 8 ounces of water while fasting, as a reference. Oral naltrexone hydrochloride was administered 12 hours and two hours prior to treatment to counter morphine effects.

There were no serious adverse events reported during the study. Most adverse events were mild to moderate, with only one severe. All adverse events resolved before the end of the study.