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Recent News and Articles on the Keywords: fda + drug + restless  Related to the article below (Last Update: 8/5/2008)


News 8 Austin
Restless Legs Syndrome may be mental or genetic
News 8 Austin, TX -
In 2005, the FDA approved the first drug to treat RLS -- ropinirole (Requip). The FDA then approved pramipexole (Mirapex) in 2006. Clinical trials have also ...
Single-Pill Combinations Diovan HCT and Exforge Approved in US as ...
MarketWatch - Aug 3, 2008
EAST HANOVER, NJ, Aug 04, 2008 /PRNewswire via COMTEX/ -- The US Food and Drug Administration (FDA) has approved two single-pill combination medications, ...

InjuryBoard.com
$8.2 Judgment Against Parkinson's Drug Mirapex
InjuryBoard.com, FL - Aug 1, 2008
Drug makers Pfizer and Boehringer Ingelheim are defendants. They say that the lawsuit conflicts with the FDA?s oversight of prescription drugs. ...
Compulsive Gambling and Mirapex Verdict $8.2 Million InjuryBoard.com
all 2 news articles »
Xenoport rises as analysts tout drug candidate
Forbes, NY - Jul 9, 2008
The drug has shown clear and positive results as a restless leg syndrome treatment and physicians are already comfortable with a key component of the drug, ...XNPT
Man held for blasts jumps to death
Khaleej Times, United Arab Emirates -
Auto-rickshaw driver Kalimuddin Sheikh, an alleged drug addict, is believed to have taken the extreme step as he had become restless after the narcotic was ...
UCB shares slide as FDA rejects lacosamide for DNP
Pharma Times (subscription), UK - Jul 30, 2008
... along with the Parkinson?s disease/restless legs syndrome treatment Neupro (rotigotine) and the anti-tumour necrosis factor alpha drug Cimzia ...
You?re Checked Out, but Your Brain Is Tuned In
New York Times, United States -
They are frustrated, restless moments. That combination, psychologists argue, makes boredom a state that demands relief ? if not from a catnap or a ...
Inside Track
Minneapolis Star Tribune, MN - Aug 3, 2008
Several hundred similar suits have been filed against Mirapex, which is also advertised to treat restless leg syndrome, and the outcome of the three trials ...
Shame on NPP
Ghana News, Ghana -
Is the social foundation not suffering progressive wreckage, and are social values not being submerged and supplanted by a restless desire for power and ...
Neurogen Corporation Announces Webcast of Second Quarter 2008 ...
MarketWatch - Aug 1, 2008
a drug development company, announced today that it will release its second quarter 2008 financial results on Thursday, August 7, 2008 before the opening of ...NRGN
Source: Google News

Giving legs to restless legs: a case study of how the media helps make people sick -
S Woloshin, LM Schwartz - PLoS Med, 2006 - medicine.plosjournals.org
... and, at the time, unpublished study [8]. In 2005, the US Food and Drug Administration
(FDA) approved ropinirole for the treatment of restless legs syndrome ...

Examination of the evidence for off-label use of gabapentin.
A Mack - J Manag Care Pharm, 2003 - ncbi.nlm.nih.gov
... approved by the US Food and Drug Administration (FDA) for adjunctive ... regional pain
syndrome, attention deficit disorder, restless legs syndrome ...

Restless legs syndrome and periodic limb movements of sleep: fact, fad, and fiction. -
S Patel - Current Opinion in Pulmonary Medicine, 2002 - co-pulmonarymedicine.com
... somnolence, ESRD end-stage renal disease, FDA The Food and Drug Administration,
ICSD ... RERA respiratory effort related arousal, RLS restless legs syndrome. ...

FDA Approvals: Requip, Entocort EC, Triglide
E Links - medscape.com
... 2005 ? The US Food and Drug Administration (FDA) has approved ropinirole HCl tablets
for the treatment of moderate to severe primary restless legs syndrome ...

Sleep Disorders Market Analysis 2008-2018
RLSRL Still, C LeadDiscovery, OS Apnoea, H … - leaddiscovery.co.uk
... Requip (ropinirole) became the first and only FDA-approved drug treatment for
moderate to severe primary Restless Legs Syndrome (RLS) in 2005. ...
-

Latest Approaches to Taming Restless Legs Syndrome
RL Syndrome, A Common, OU Condition - medscape.com
... Restless legs syndrome (RLS) has received much attention in the past year ... in
mid-2005 that the US Food and Drug Administration (FDA) had approved ...
-

[CITATION] Glaxo Says FDA Has Questions on Extended-Release Requip for Restless Legs
L In

[CITATION] Glaxo Says FDA Has Questions on Extended-Release Requip for Restless Legs
CME Tracker

FDA targets unapproved drugs. -
D Young - American Journal of Health-System Pharmacy, 2007 - pt.wkhealth.com
... mar- keting approval for that drug in August ... label conditions, primarily for leg
cramps, according to FDA. ... the treatment or prevention of restless legs syndrome ...
-

RESTLESS LEGS SYNDROME: QUALITY OF LIFE IS IMPAIRED, DOPAMINE AGONIST EFFECTIVE.
R Robinson - Neurology Today, 2003 - neurotodayonline.com
... HONOLULU - Restless legs syndrome (RLS) affects as many as 10 percent of ... RLS because
it has been Food and Drug Administration (FDA)-approved for ...

Source: Google Scholar
 
 

FDA approves first drug for Restless Legs Syndrome

 
 
FDA ( Food and Drug Administration ) has approved Ropinirole ( Requip ), an orally administered anti-Parkinsonian drug, for the treatment of moderate-to-severe primary Restless Legs Syndrome ( RLS ) in adults.

Requip is the first FDA-approved treatment for patients with moderate-to-severe primary RLS, a chronic and disruptive neurological condition.

Identified in the early 1940's by neurologist Karl Ekbom, Restless Legs Syndrome is characterized by a compelling urge to move the legs and by uncomfortable or sometimes painful sensations in the legs often described as creeping-crawling, tingling, pulling or tightening.
Symptoms of RLS generally occur at rest, such as when sitting, lying or sleeping, and are temporarily relieved by movement. These symptoms can significantly disrupt a patient's sleep and daily activities. People with RLS often have difficulty falling and staying asleep and can feel less alert during the day.

Requip is a second-generation dopamine agonist that directly stimulates dopamine receptors in the brain.

Although its exact cause is unknown, researchers believe that the underlying cause of RLS may be related to dopamine, a chemical that carries the signals between nerve cells that control body movement.
When the dopamine system does not function properly, it may upset the normal communication of these signals.

The approval of Requip for moderate-to-severe primary Restless Legs Syndrome is supported by data from four double-blind, randomized, placebo- controlled clinical trials in adults diagnosed with RLS.

Patients with RLS secondary to other conditions ( e.g. iron deficiency, pregnancy and renal failure ) were excluded from the study groups.

In the most recently completed U.S. trial, Requip significantly improved symptoms of moderate-to-severe primary RLS in patients from baseline to week 12, according to two validated measurement tools: the International RLS Rating Scale ( IRLS Scale ) and Clinical Global Impression-Global Improvement ( CGI-I ) scale.

Patients taking Requip achieved a significantly greater mean improvement in IRLS Rating Scale total score compared to the placebo group ( -13.5 points versus -9.8 points, respectively; p<0.0001 ) and significantly more patients taking Requip showed a "much improved" or "very much improved" score on the CGI-I scale compared with the placebo group ( 73.3 percent versus 56.5 percent, respectively; p=0.0006 ).

In two other similarly designed trials, Requip also significantly improved IRLS Rating Scale and CGI-I scale scores from baseline to week 12.

Long-term maintenance of efficacy in the treatment of RLS was demonstrated in a 36-week relapse prevention study.
In this trial, patients taking Requip demonstrated a significantly lower relapse rate compared with patients randomized to placebo ( 32.6 percent vs. 57.8 percent, p=0.0156 ).

In clinical trials in the treatment of moderate-to-severe primary RLS, the most commonly observed adverse events for Requip versus placebo were nausea ( 40 percent versus 8 percent ), somnolence ( 12 percent versus 6 percent ), vomiting ( 11 percent versus 2 percent ), dizziness ( 11 percent versus 5 percent ) and fatigue ( 8 percent versus 4 percent ). Occurrences of nausea in clinical trials were generally mild to moderate in intensity.

Many people with RLS report a significant impact on their daily activities.
In addition to feeling less alert during the day, RLS sufferers may also have difficulty with activities that require prolonged sitting such as movies, long car rides or airline flights.
Difficulty falling asleep may frequently be associated with moderate-to-severe primary RLS.

Women account for approximately two-thirds of RLS sufferers, although RLS occurs in both men and women.

RLS is generally a chronic condition, and the frequency of RLS symptoms tends to increase with age.

A genetic component has been suggested for patients with primary RLS.
Clinical data demonstrate a positive family history of the disorder in as many as 50 percent of affected individuals.

When evaluating patients' symptoms of RLS, it is important for healthcare providers to rule out other underlying conditions that are associated with secondary RLS symptoms, such as iron deficiency, pregnancy and renal failure.

Despite the prevalence of RLS, it frequently remains under-diagnosed.
A wide range of other diagnoses, including back pain, depression, arthritis, nocturnal cramps, insomnia and neuropathy have been given to patients who present with symptoms of RLS.

Source: GSK, 2005
 
 
 
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