Navigation Links
KADIAN Efficacy Not Affected by Alcohol Consumption

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.

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? 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 oun ces 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.

Source-Eurekalert
PRI
'"/>




Related medicine news :

1. Efficacy Of Meningitis C Vaccine
2. The Efficacy Of Allergy Shots Questioned
3. The Efficacy Of Newer Stents Questioned
4. The Efficacy Of Hormone Replacement Therapy Studied
5. Ambiguous Efficacy Of Opioid Drugs In Chronic Inflammatory Joint Pain Relief
6. Efficacy of fish oil supplements in pregnancy.
7. Efficacy of Omega 3 Fatty Acids Needs Wider Perspective
8. Thailand To Test Efficacy Of Stem Cell Technology
9. Efficacy Of Sports-Formulated Jelly Beans In Warding Off Fatigue To Be Studied
10. Indian And Chinese Doctors Join Together To Prove The Efficacy Of Herbal Drugs
11. New Study Shows Efficacy of AROMASIN on Early Breast Cancer
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:5/25/2016)... ... May 25, 2016 , ... TransactRx announces the release of ... medical service claims by Pharmacy Benefit Managers that were submitted by Retail Clinics ... TransactRx Cross Benefit Clearinghouse receives standard professional medical claims submitted from the retail ...
(Date:5/25/2016)... FRANCISCO, CA (PRWEB) , ... May 25, 2016 , ... ... School of Nursing and Health Professions. She will lead a team of more than ... Team. Baker will begin her role as dean in late August. , Baker comes ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... Laser ... to help turn back the hands of time of female aging. The ... childbirth. Women with symptoms such as leakage, laxity, itchiness and pain have reported ...
(Date:5/25/2016)... NJ (PRWEB) , ... May 25, 2016 , ... Researchers ... 2016 Annual COVD Meeting for their work on visual evoked potential and human attention. ... recent studies that used the Diopsys® NOVA™ ERG and VEP Vision Testing System ...
(Date:5/25/2016)... ... May 25, 2016 , ... HealthPostures ... will join America's leading engineers at the American Society of Safety Engineers Conference ... Congress Center. , Engineers, speakers and exhibitors from more than 40 countries ...
Breaking Medicine News(10 mins):
(Date:5/24/2016)... 24, 2016 Niederländische Chirurgen ... die es Ärzten erlaubt, ihre Expertise weltweit zu ... kombiniert Live Streaming mit einer Instant-Messaging-Funktion und der ... Mediziner in Europa, Afrika, Asien und den ... die Plattform registriert. Information und Weiterbildung   ...
(Date:5/24/2016)... 2016  Diana Russell suffers from a form of ... inside out.  This disease has put her in a ... and grandchildren to leave her home.  Because of the ... haul the wheelchair.  So if there is a family ... is left to wait for the bus. ...
(Date:5/24/2016)... Marziani has joined VMS BioMarketing as senior vice president of sales, announced Andrea ... Marziani will lead the company,s business development and sales team, exploring new opportunities for ... - http://photos.prnewswire.com/prnh/20160523/371089 ... ... ...
Breaking Medicine Technology: