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 http://www.KADIAN.com.
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.
http://www.alpharma.com
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