The results of Phase IV study of KADIAN ® (morphine sulfate extended-release) Capsules have been released by Alpharma Inc. (NYSE: ALO), a leading pharmaceutical company. It reveals that 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® 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®, and we will continue to educate clinicians and patients about the appropriate use of KADIAN® for moderate-to-severe chronic pain. Like most medications, KADIAN® should not be taken with alcohol."
These results indicate that the concomitant use of tested levels of alcohol with KADIAN® 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.
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® 100 mg with ethanol (8 ounces of 40 percent alcohol) while fasting;
KADIAN® 100 mg with ethanol (8 ounces of 40 percent alcohol) while fed;
KADIAN® 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.