Restless Leg Syndrome drug, REQUIP®, approved by FDA

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Restless Leg Syndrome drug, REQUIP®, approved by FDA

07 May 2005 Medical News Today

The US FDA has approved Requip® (ropinirole HCl) Tablets for the

treatment of moderate-to-severe primary Restless Legs Syndrome (RLS)

in adults, GlaxoKline announced today. Requip is the first and

only FDA-approved treatment for those patients with moderate-to-

severe primary RLS, a chronic and disruptive neurological condition.

RLS, which encompasses a range of severity that includes mild,

moderate and severe symptoms, affects approximately one in ten adults

in the U.S. Identified in the early 1940's by neurologist Dr. Karl

Ekbom, RLS 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.

" Throughout our clinical research program for Restless Legs Syndrome,

we've had the opportunity to speak with many people who suffer from

this condition, and we've heard first-hand about how difficult life

can be for them, " said Viehbacher, President, U.S.

Pharmaceuticals, GlaxoKline. " With the approval of Requip for

moderate-to-severe primary RLS, we're proud to be able to offer

effective relief to millions of people who live with this condition,

many of whom have suffered for years without treatment. "

" For me, the most difficult aspect of living with RLS has been the

urge to move my legs during times when I just want to relax or when I

am trying to fall asleep, " said Ellen Onufrow. " Several times a

week I feel very unpleasant sensations in my legs that are difficult

to describe, and the only way to get rid of them is to get up and

move around. These symptoms had a significant impact on many aspects

of my life including my sleep and my daily activities. Thanks to

Requip, my symptoms are under control, and I am able to turn my

attention back to my family, friends and work, instead of on my RLS. "

Requip® Proven Effective in Treating Moderate-to-Severe Primary RLS

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. " One of the principal benefits of treatment with Requip is

relief of the urge to move the legs, " said Dr. Ondo,

Associate Professor of Neurology at Baylor College of Medicine,

Houston, Texas. " Requip targets what doctors believe may be an

underlying cause of the disorder, which is dysfunction of a system

involving the brain chemical dopamine. Now there is an approved

treatment specifically for moderate-to-severe primary RLS which

should help to validate this under-recognized and misunderstood

condition. "

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 that took place in centers largely outside of the

U.S., 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 (n=496) versus placebo (n=500)

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. About RLS In general, 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. In addition, 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 health

care 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.

Important Safety Information About Requip®

Requip may cause patients to fall asleep or feel very sleepy while

doing normal activities such as driving; or to feel faint or dizzy,

nauseated or sweaty, when they stand up from sitting or lying down.

If patients experience these problems, they should talk to their

doctor.