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Ilow · 05-20-2005, 08:39 PM

found this on Yahoo.com tonite. coincidence?

Leg Ailment Patients Might Get A Kick Out Of FDA Approval Amy Reeves
Fri May 20, 7:00 PM ET

When GlaxoSmithKline (NYSE:GSK - News) recently announced that its drug Requip had been approved for restless legs syndrome, the public likely was divided into two responses: "Finally!" and "Uh, what is that exactly?"

Restless legs syndrome, or RLS, is actually a common ailment. Experts figure that as many as 8% of Americans suffer from it to some degree. Until recently, though, an approved treatment for it hasn't surfaced.

As the name suggests, RLS give sufferers a strong compulsion to move their legs. It's not always painful, but it is uncomfortable.

Patients describe the sensation as a pulling, tingling or buzzing feeling in the legs. Some say it feels like bugs are crawling on their legs. This usually happens during the early evening or at night.

Most sufferers are middle-aged and older, though RLS does occur in young people. Pregnant women also seem to get it. Women are slightly more likely to get it than men.

If the attacks are infrequent, they're a nuisance. When people get RLS severely, it can impair sleep.

About 80% of RLS sufferers also suffer periodic leg movements while sleeping, which makes it difficult for them to get a decent night's sleep. This causes the same symptoms as chronic insomnia: fatigue and loss of mental alertness.

The ailment was first named in the 1940s. For the next 50-odd years it didn't get much attention from the medical industry.

"It's just been in the last 10 years that researchers have been doing studies that show this fairly common disorder affects people in a meaningful way," said Georgianna Bell, president of the RLS Foundation. "It affects quality of life to the point where some people can't work."

Happy Accident

Part of the problem with finding a treatment was the fact that nobody knows exactly what causes RLS. It seems to run in families.

It has been tied to such diverse factors as anemia, pregnancy, neurological legions, kidney failure and drug abuse. But a person may have none of those conditions and still get it.

In the course of treating other diseases, doctors sometimes discover a drug has a happy side effect that helps another ailment. That's the case with Requip, which was already on the market as a treatment for Parkinson's disease.

"It was approved for Parkinson's, but as is sometimes the case, physicians will begin to understand that a drug can have a beneficial effect in other ways," said Glaxo spokeswoman Nancy Pekarek. "So Glaxo began to study for those indications."

Glaxo chose patients with moderate to severe RLS and put them on a much lower dose of Requip than is used for Parkinson's. Three-quarters of them reported their symptoms were "much improved."

Company officials are reluctant to estimate how this will impact Requip's market. Part of the problem is defining "moderate to severe" RLS.

Glaxo used its own definition for its study, but it's tough to predict how many of the 10 million U.S. sufferers have it badly enough to be willing to go on medication.

Glaxo's study also included only patients who have RLS without secondary causes such as anemia or kidney failure.

Still, since the disease is tied to age, the market will likely only get bigger. For that reason, some other big drug makers, including Germany's Boehringer Ingelheim and Schwartz Pharma, are looking into whether their drugs might have an RLS benefit.

If nothing else, Bell says Glaxo's move should raise awareness of RLS among doctors, drug makers and the public.

"Many more physicians are going to be educated about this condition," she said. "Nowadays if somebody comes into a doctor's office and says they have a funny sensation like snakes crawling on their legs, the doctor might think it's a psychiatric condition. All kinds of misdiagnoses occur."

Glaxo won't reveal its marketing plans for Requip.

Bell expects the firm will advertise to the general public, prompting sufferers who were reluctant to visit the doctor for their strange symptoms to go ask for treatment.

"A lot of people don't know that the real condition under its real name is actually treatable," said Bell. "We're very excited about that."

05-20-2005, 08:39 PM	#24 (permalink)
Ilow Junkie Location: Pats country	found this on Yahoo.com tonite. coincidence? Leg Ailment Patients Might Get A Kick Out Of FDA Approval Amy Reeves Fri May 20, 7:00 PM ET When GlaxoSmithKline (NYSE:GSK - News) recently announced that its drug Requip had been approved for restless legs syndrome, the public likely was divided into two responses: "Finally!" and "Uh, what is that exactly?" Restless legs syndrome, or RLS, is actually a common ailment. Experts figure that as many as 8% of Americans suffer from it to some degree. Until recently, though, an approved treatment for it hasn't surfaced. As the name suggests, RLS give sufferers a strong compulsion to move their legs. It's not always painful, but it is uncomfortable. Patients describe the sensation as a pulling, tingling or buzzing feeling in the legs. Some say it feels like bugs are crawling on their legs. This usually happens during the early evening or at night. Most sufferers are middle-aged and older, though RLS does occur in young people. Pregnant women also seem to get it. Women are slightly more likely to get it than men. If the attacks are infrequent, they're a nuisance. When people get RLS severely, it can impair sleep. About 80% of RLS sufferers also suffer periodic leg movements while sleeping, which makes it difficult for them to get a decent night's sleep. This causes the same symptoms as chronic insomnia: fatigue and loss of mental alertness. The ailment was first named in the 1940s. For the next 50-odd years it didn't get much attention from the medical industry. "It's just been in the last 10 years that researchers have been doing studies that show this fairly common disorder affects people in a meaningful way," said Georgianna Bell, president of the RLS Foundation. "It affects quality of life to the point where some people can't work." Happy Accident Part of the problem with finding a treatment was the fact that nobody knows exactly what causes RLS. It seems to run in families. It has been tied to such diverse factors as anemia, pregnancy, neurological legions, kidney failure and drug abuse. But a person may have none of those conditions and still get it. In the course of treating other diseases, doctors sometimes discover a drug has a happy side effect that helps another ailment. That's the case with Requip, which was already on the market as a treatment for Parkinson's disease. "It was approved for Parkinson's, but as is sometimes the case, physicians will begin to understand that a drug can have a beneficial effect in other ways," said Glaxo spokeswoman Nancy Pekarek. "So Glaxo began to study for those indications." Glaxo chose patients with moderate to severe RLS and put them on a much lower dose of Requip than is used for Parkinson's. Three-quarters of them reported their symptoms were "much improved." Company officials are reluctant to estimate how this will impact Requip's market. Part of the problem is defining "moderate to severe" RLS. Glaxo used its own definition for its study, but it's tough to predict how many of the 10 million U.S. sufferers have it badly enough to be willing to go on medication. Glaxo's study also included only patients who have RLS without secondary causes such as anemia or kidney failure. Still, since the disease is tied to age, the market will likely only get bigger. For that reason, some other big drug makers, including Germany's Boehringer Ingelheim and Schwartz Pharma, are looking into whether their drugs might have an RLS benefit. If nothing else, Bell says Glaxo's move should raise awareness of RLS among doctors, drug makers and the public. "Many more physicians are going to be educated about this condition," she said. "Nowadays if somebody comes into a doctor's office and says they have a funny sensation like snakes crawling on their legs, the doctor might think it's a psychiatric condition. All kinds of misdiagnoses occur." Glaxo won't reveal its marketing plans for Requip. Bell expects the firm will advertise to the general public, prompting sufferers who were reluctant to visit the doctor for their strange symptoms to go ask for treatment. "A lot of people don't know that the real condition under its real name is actually treatable," said Bell. "We're very excited about that." __________________ "Religion is the one area of our discourse in which it is considered noble to pretend to be certain about things no human being could possibly be certain about" --Sam Harris