Navigation Links
FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
Date:10/12/2010

SILVER SPRING, Md., Oct. 12 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

(Logo:  http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Vivitrol is an extended-release formulation of naltrexone administered by intramuscular injection once a month. Naltrexone works to block opioid receptors in the brain. It blocks the effects of drugs like morphine, heroin, and other opioids. It was approved to treat alcohol dependence in 2006.

"Addiction is a serious problem in this country, and can have devastating effects on individuals who are drug-dependent, and on their family members and society," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. "This drug approval represents a significant advancement in addiction treatment."

The safety and efficacy of Vivitrol were studied for six months, comparing Vivitrol treatment to placebo treatment in patients who had completed detoxification and who were no longer physically dependent on opioids. Patients treated with Vivitrol were more likely to stay in treatment and to refrain from using illicit drugs. Thirty-six percent of the Vivitrol-treated patients were able to stay in treatment for the full six months without using drugs, compared with 23 percent in the placebo group.

Patients must not have any opioids in their system when they start taking Vivitrol; otherwise, they may experience withdrawal symptoms from the opioids. Also, patients may be more sensitive to opioids while taking Vivitrol at the time their next scheduled dose is due. If they miss a dose or after treatment with Vivitrol has ended, patients can accidentally overdose if they restart opioid use.

Side effects experienced by those using Vivitrol included nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps. Other serious side effects included reactions at the site of the injection, which can be severe and may require surgical intervention, liver damage, allergic reactions such as hives, rashes, swelling of the face, pneumonia, depressed mood, suicide, suicidal thoughts, and suicidal behavior.

Vivitrol should be administered only by a physician as an intramuscular injection, using special administration needles that are provided with the product. Vivitrol should not be injected using any other needle. The recommended dosing regimen is once a month.

Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Vivitrol is manufactured by Alkermes, Inc.

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... Feb.8, 2016 Cardiac Assist ... Summary GlobalData,s Medical Devices sector report, " ... 2015 " provides an overview of Cardiac Assist ... provides comprehensive information on the pipeline products with ... of development. The report reviews major players involved ...
(Date:2/8/2016)... Devices - Medical Devices Pipeline Assessment, 2015 Summary ... Medical Devices Pipeline Assessment, 2015" provides an overview of ... This report is prepared using data sourced from in-house ... industry experts. *Note: Certain sections in the report ... and relevance of data in relation to the equipment ...
(Date:2/8/2016)...  Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) announced ... and year-end 2015 results after the Nasdaq market closes ... a live conference call and webcast to discuss its ... February 11, 2016 at 4:30 p.m. Eastern Time (1:30 ... http://www.neurocrine.com . --> Participants can access ...
Breaking Medicine Technology:
(Date:2/9/2016)... Altamonte Springs, FL (PRWEB) , ... February 09, ... ... nation’s leading innovative specialty pharmacies, announces today the continuation of the ‘Pay It ... donations for each prescription referral received at our specialty pharmacy. , “Since ...
(Date:2/9/2016)... ... February 09, 2016 , ... On January 12, 2016 Paul McElwee, ... after they noticed their furnace not producing any heat. Shortly after entering the home, ... heat exchanger was leaking dangerous levels of carbon monoxide into the home, at 2,000 ...
(Date:2/9/2016)... WI (PRWEB) , ... February 09, 2016 , ... ... Bergner’s, Boston Store, Carson’s, Elder-Beerman, Herberger’s and Younkers department stores, announced it has ... College of Wisconsin Cancer Center, Holden Comprehensive Cancer Center at the University of ...
(Date:2/9/2016)... Diego, California (PRWEB) , ... February 09, 2016 ... ... launch of their new nationwide service to expand access to affordable hearing ... 30 million hard of hearing individuals in the United States. , “For the ...
(Date:2/9/2016)... ... February 09, 2016 , ... IsoComforter, Inc., one of the ... newly designed, innovative shoulder wrap. The newly designed shoulder wrap has been ... arm and shoulder to promote faster healing. It is highly recommended for arm ...
Breaking Medicine News(10 mins):