Alpharma Inc. (NYSE:
ALO), a leading global specialty pharmaceutical company, presented results
of a Phase IV study of KADIAN(R) (morphine sulfate extended-release)
Capsules that demonstrate the pharmacokinetics of the long-acting opioid
are not significantly affected by the consumption of alcohol. Results of
this pharmacokinetic study, which Alpharma conducted in response to a
request by the U.S. Food and Drug Administration (FDA) to assess whether
alcohol interferes with the extended-release mechanism of action in
long-acting opioids, were presented yesterday at the 23rd Annual Meeting of
the American Academy of Pain Medicine (AAPM) in New Orleans, LA.
"This study demonstrated that the extended-release properties of
KADIAN(R) were maintained even in the presence of a significant quantity of
alcohol," says Joseph Stauffer, DO, Vice President, Clinical Research &
Medical Affairs, Alpharma Pharmaceuticals Division Inc. "We believe this
information is valuable for doctors in their assessment of KADIAN(R), and
we will continue to educate clinicians and patients about the appropriate
use of KADIAN(R) for moderate-to-severe chronic pain. Like most
medications, KADIAN(R) should not be taken with alcohol."
These results indicate that the concomitant use of tested levels of
alcohol with KADIAN(R) 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.
Study Design
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:
-- KADIAN(R) 100 mg with ethanol (8 ounces of 40 percent alcohol) while
fasting;
-- KADIAN(R) 100 mg with ethanol (8 ounces of 40 percent alcohol) while
fed;
-- KADIAN(R) 100 mg with 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 2 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, and one was severe, chest pain. All
adverse events resolved before the end of the study.
This study was supported by Alpharma Inc.'s Pharmaceuticals Division,
which has a growing franchise in chronic pain treatment.
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 are available in six strengths: 20 mg, 30 mg, 50 mg, 60 mg, 80
mg and 100 mg. The 100 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,
hypotension 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.
About Alpharma Inc.
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.
Statements made in this release include forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995.
These statements, including those relating to future financial
expectations, involve certain risks and uncertainties that could cause
actual results to differ materially from those in the forward-looking
statements. The 2006 outlook assumes no material adverse event contemplated
by the risk factors described in the Company's SEC filings. Information on
other significant potential risks and uncertainties not discussed herein
may be found in the Company's filings with the Securities and Exchange
Commission including its Form 10-K for the year ended December 31, 2005.
Alpharma Inc.
alpharma
View drug information on Naltrexone Hydrochloride Tablets.