ALPHARMA'S KADIAN 200-MG STRENGTH APPROVED

Alpharma announced it was notified by the FDA that its application for Kadian 200-mg capsules has received approval. The company expects to launch this new dosage strength in the second quarter of 2007.

Kadian (morphine sulfate extended-release) is Alpharma's branded extended-release morphine sulfate product and is currently marketed in 20-, 30-, 50-, 60-, 80- and 100-mg dosages. The added dosage strength is intended to assist in physicians' efforts to individualize their patients' treatments by offering more choices in managing their pain.

In 2006, the company conducted in vivo studies to evaluate the interaction of alcohol consumption with Kadian. The results indicated that the concomitant use of tested levels of alcohol with Kadian had no significant effect on mean morphine blood levels. The FDA has completed a review of this data and has concluded that the Kadian black-box warning does not need to include any precautionary language related to alcohol. The company believes that the exclusion of this precautionary language will help further differentiate Kadian in the marketplace.

Kadian capsules are an extended-release formulation of morphine sulfate indicated for the management of moderate-to-severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Capsules can be taken once daily or twice daily to provide up to 24 hours of pain relief. Capsules will now be available in seven strengths: 20, 30, 50, 60, 80, 100 and 200 mg. The 100- and 200-mg capsules are for use in opioid-tolerant patients only.