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:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... ... an official 2017 partnership with The Jensie Gran Fondo of Marin. For the ... UVB rays with Thinksport’s broad-spectrum, mineral-based sunscreen. , “We are thrilled to provide ...
(Date:2/23/2017)... ... 2017 , ... The American Cleft Palate-Craniofacial Association (ACPA) is pleased to announce ... a longtime supporter of the event. , "We are pleased that KLS Martin is ... Havlik, 2017 ACPA President. "KLS Martin has a long track record of support of ...
(Date:2/23/2017)... ... February 23, 2017 , ... On April 13, ... symposium on “Doping in Sport: How the Culture Might Change,” in ... LLP. The symposium will be held at Pepperdine University in Malibu, California. , ...
(Date:2/23/2017)... ... February 23, 2017 , ... Healthcare ... for those in the fight against cancer, has produced a seminal study that ... HRA will release top-line findings in a webinar, Defining Compassionate Care Through the ...
(Date:2/23/2017)... York (PRWEB) , ... February 23, 2017 , ... Curemark, ... the safety and efficacy of CM-AT in children aged 3-8 with Autism, is now ... clinical sites already enrolling children across the United States. , “There are currently ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... NEW YORK , Feb. 23, 2017  This ... US$ Thousand by the following Products: ... analyzed in the report include Pharmaceuticals, and Agrochemicals. The ... Japan , Europe , ... provided for the period 2015 through 2022. Also, a ...
(Date:2/24/2017)... -- Research and Markets has announced the addition of ... report to their offering. ... The latest research Urinary Incontinence Drugs Price Analysis ... the global Urinary Incontinence market. The research answers the following ... marketed for Urinary Incontinence and their clinical attributes? How are they ...
(Date:2/23/2017)... Feb. 23, 2017  Cogentix Medical, Inc. (NASDAQ: CGNT), ... innovative proprietary products for the urology market, will release ... ended December 31, 2016 before the market open on ... will host a conference call and webcast to discuss ... 9, 2017 at 11:00 a.m. Eastern Time (10:00 a.m. ...
Breaking Medicine Technology: