Navigation Links
U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
Date:6/13/2008

and director of the Parkinson's Disease and Movement Disorder Center at the University of Kansas Medical Center in Kansas City. "Requip XL provides continuous delivery of ropinirole over 24 hours to provide smoother blood levels without the peaks and troughs that multiple daily doses typically deliver. It is an important once-daily treatment option for patients with Parkinson's disease."

Requip XL is an extended-release, once-daily tablet formulation that uses SkyePharma PLC's (LSE: SKP) patented GEOMATRIX(TM) technology. This innovative tri-layer formulation allows for continuous delivery of ropinirole over 24 hours to provide smooth blood levels. Requip XL offers physicians and patients a simple titration regimen; it also offers a convenient, once-daily dosing schedule compared to other oral dopamine agonists, which are dosed multiple times a day.

Clinical Study

FDA approval was based primarily on results from the EASE-PD (Efficacy And Safety Evaluation in Parkinson Disease) Adjunct Study, a multi-center, double-blind, placebo-controlled study conducted in patients with idiopathic Parkinson's disease not adequately controlled with l-dopa. A total of 393 patients in the study were randomized to receive either Requip XL (n=202) or placebo (n=191) once daily for 24 weeks in addition to l-dopa. The study's primary endpoint was the mean change from baseline at week 24 in awake time spent "off," which was measured via patient diaries. Results from the study showed that Requip XL significantly reduced "off" time by an average of 2.1 hours per day from baseline, compared to a reduction of 0.4 hours per day for placebo.

Once-daily use of Requip XL was generally well tolerated in the study. The withdrawal rate due to adverse reactions was low and similar between groups (6 percent Requip XL vs. 5 percent placebo). The most common adverse reactions reported in patients taking Requip XL compared to placebo were dyskinesia (13 percent vs. 3 percent),
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
2. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
3. 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
4. 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)
5. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
8. 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
9. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
10. 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
11. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... a third of reproductive-aged women enrolled in Medicaid, and more ... prescription for an opioid pain medication each year during 2008-2012, ... Weekly Report (MMWR). Opioids are typically prescribed ... They are also found in some prescription cough medications. The ...
(Date:1/23/2015)...  HyGreen, Inc., a leader in hand hygiene monitoring, today ... a subsidiary of Ascendis Health Limited, in ... hundreds of millions of patients around the world are ... from patient to patient via the unwashed hands of ...
(Date:1/23/2015)... 23, 2015 Cord Blood America, Inc. ( www.cordblood-america.com ) ... "Company")  filed a Preliminary Proxy Statement, Schedule 14A, with the ... provides an update for shareholders detailing why a "YES" vote ... Dear Shareholders, As we reflect upon the ...
Breaking Medicine Technology:Opioid painkillers widely prescribed among reproductive age women 2Opioid painkillers widely prescribed among reproductive age women 3HyGreen Partners with RCA Medical in Johannesburg, South Africa 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 2Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 3Cord Blood America Announces Preliminary Proxy Filing and Details Why a "YES" Vote to Increase Authorized Shares Is Requested 4
(Date:1/22/2015)... Blue Cross and Blue Shield of Minnesota ... it means to “Live Fearless.” , The “Faces ... their stories about how they or someone they know has ... living in the moment. By telling these types of stories ...
(Date:1/22/2015)... A new white paper by The ... in the long-term care environment as well as provides ... The paper, “The Power of Person-Centeredness in Long-Term Care: ... of the patient, resident and family experience in long-term ...
(Date:1/22/2015)... has released a new blog post presenting the basic features ... Purchasing an accidental death and dismemberment rider for a car ... provides benefits if the insured dies in an accident. Accidental ... life insurance. , AD&D is not expensive and can ...
(Date:1/22/2015)... Recently, Weddingshe.com has added many trendy Champagne wedding ... annual revenues in the past three years. Today, the business ... , According to the sales manager of the company, this ... in 2015. This point can be reflected on the discounted ...
(Date:1/22/2015)... EBSCO Information Services (EBSCO) and ... relationship in an effort to further promote visibility and adoption ... has long made AMA journals available via its subscription services, ... JAMA Network. , Long known as both a ...
Breaking Medicine News(10 mins):Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 2Health News:The Power of Person-Centeredness in Long-Term Care Explored by The Beryl Institute 3Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:Weddingshe Announces A Special Offer On Its Popular Glamorous Wedding Dresses 2Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4
... and Silences Opposition DebateCHESAPEAKE, Va., April 28 ... will lack the necessary 60 votes required to ... and Senate Democrats last night struck a back-room ... debate and drops the number of needed votes ...
... The Third Annual AmeriCorps Week (May 9-16) hopes ... are having across America every day. There are ... year, assisting at-risk youth, providing services for the ... nonprofits in volunteer recruitment and achieving their vision. ...
... 28 Penn Foster Career School, one of the ... has launched a new Certified Personal Trainer Program.With Penn ... training in the techniques and skills of a Personal ... (NCSF) Certification Package that contains materials that will prepare ...
... of steam, expert says, , , TUESDAY, April 28 (HealthDay News) ... smoke and keep a healthy blood pressure level. , Each ... among U.S. adults, according to new research. , Although both ... death, the magnitude of the effect found in the new ...
... Young Adults, Testing Rates Are StagnantAmidst Call for Stepped ... for More Spending and the Public Believes Greater Efforts ... Less than a year after the Centers for Disease ... HIV/AIDS epidemic and announced that there were 40 percent ...
... are the only sector of the health care industry ... that to change.(Photo: http://www.newscom.com/cgi-bin/prnh/20090428/PH06755 ... for a National Health Insurer Code of Conduct. The ... integrity and patient safety and welfare. I commend the ...
Cached Medicine News:Health News:Fast-Track of Socialized Healthcare Imminent 2Health News:Third Annual AmeriCorps Week 2Health News:Third Annual AmeriCorps Week 3Health News:Penn Foster Career School Launches Online Certified Personal Trainer Program 2Health News:Smoking, Hypertension Each Account for 1 in 5 U.S. Deaths 2Health News:Less Than a Year After CDC Announced the U.S. HIV Epidemic Is Much Larger Than Previously Thought, Public's Sense of Urgency Is Down, Even Among Some Higher Risk Groups 2Health News:Less Than a Year After CDC Announced the U.S. HIV Epidemic Is Much Larger Than Previously Thought, Public's Sense of Urgency Is Down, Even Among Some Higher Risk Groups 3Health News:Less Than a Year After CDC Announced the U.S. HIV Epidemic Is Much Larger Than Previously Thought, Public's Sense of Urgency Is Down, Even Among Some Higher Risk Groups 4Health News:For Patients' Sake, Insurance Companies Urgently Need a Code of Conduct 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: