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 KADIAN.
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.
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