ALPHARMA RECEIVES APPROVAL FOR 80-MG KADIAN CAPSULES

Alpharma announced it has been notified by FDA that its pending application for Kadian 80-mg capsules has received approval. The company expects to launch this new dosage strength in the fourth quarter of 2006.

Kadian is Alpharma's branded sustained-release morphine sulfate product and is currently marketed in 20-, 30-, 50-, 60- and 100-mg dosages. The added dosage strength is intended to assist physicians' efforts to individualize their patient's treatments by offering more choices in managing their pain.

The company has conducted in vivo studies to evaluate the interaction of alcohol consumption with Kadian. The results indicate that the concomitant use of tested levels of alcohol with Kadian has no significant impact on mean morphine blood levels. The company has provided this data to the FDA, and any future labeling implications will be determined following the completion of this review. Kadian product labeling, pending completion of this FDA review, will include the Schedule II extended-release opioid box warning, excluding any precautionary language related to alcohol.