FDA Approves Alpharma's KADIAN(R) New 200 Mg Strength

Main Category: Pain / Anesthetics
Article Date: 02 Mar 2007 - 0:00 PDT

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Alpharma Inc. (NYSE: ALO), a global specialty pharmaceutical company, today announced that it has been notified by United States Food and Drug Administration("FDA") that its pending application for KADIAN(R) 200mg capsule has received approval. The company expects to launch this new dosage strength in the second quarter of 2007. KADIAN(R) is Alpharma's branded extended release morphine sulfate product and is currently marketed in 20 mg, 30 mg, 50 mg, 60 mg, 80 mg and 100 mg dosages. The added dosage strength is intended to assist in physicians' efforts to individualize their patient's 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(R). The results indicated that the concomitant use of tested levels of alcohol with KADIAN(R) had no significant impact on mean morphine blood levels. The FDA has completed a review of this data and has concluded that the KADIAN(R) 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(R) in the marketplace.

About KADIAN(R) Capsules

KADIAN(R) (morphine sulfate extended-release) 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 (q24h) or twice-daily (q12h), as prescribed, to provide up to 24 hours of pain relief. Capsules will now be available in seven strengths: 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg and 200 mg. The 100 mg and 200 mg capsules are for use in opioid-tolerant patients only. KADIAN(R) offers flexible dosing and administration options that allow physicians to fine tune titration schedules and tailor treatment for individual patient needs.

KADIAN(R) may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, abnormally low blood pressure and profound sedation or coma may result.

KADIAN(R) side effects are generally consistent with those found with other opioids. The most common include drowsiness, constipation, nausea, dizziness and anxiety. Serious adverse reactions that may be associated with KADIAN(R) include respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, low blood pressure and/or shock.

KADIAN(R) Capsules contain an opioid agonist which is a Schedule II controlled substance. KADIAN(R) has an abuse liability similar to other opioids. This should be considered when prescribing or dispensing KADIAN(R).

For complete prescribing information, visit http://www.KADIAN.com.

Alpharma Inc. (NYSE: ALO) is a global specialty pharmaceutical company with leadership positions in products for humans and animals. Alpharma is presently active in more than 60 countries. Alpharma has a growing branded franchise in the chronic pain market with its morphine-based extended release KADIAN(R) product. In addition, Alpharma is among the world's leading producers of several specialty pharmaceutical-grade bulk antibiotics and is internationally recognized as a leading provider of pharmaceutical products for poultry and livestock.

Alpharma press releases are also available at our website: http://www.alpharma.com.

Alpharma Inc.
http://www.alpharma.com

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