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By Herb Newborg

End of Patent on Drugs May Mean the End of Restless Leg Syndrome
The leg twitch people were led to believe was a disease worthy of drug treatment may fade into oblivion.

Some people swear their restless legs won’t stop moving. Others swear the syndrome is largely invented or, at the least, hyped to incredible levels. Whatever the creepy, crawly truth, a new FDA decision could slow the onslaught of Restless Leg Syndrome (RLS) ads, MSNBC writes.

Last year, the agency approved the first generic versions of Glaxo’s Requip for four manufacturers, and the move is likely to send Requip sales and advertising plummeting, industry experts predicted. At least one sleep disorder specialist expects the focus on the syndrome to fade as rapidly as the Requip television commercials - which have already been pulled from the airwaves.

“Restless legs syndrome is a great example of a suddenly out-of-the-blue disease,” Christopher Earley, an associate professor of neurology at Johns Hopkins University in Baltimore who treats the disorder, tells MSNBC. “I would anticipate there would be something of a fall-off,” Earley said, adding: “I think we need to take the kettle off the stove and let it cool down a bit.”

“I think there certainly has been awareness about restless legs syndrome since the approval of (Reqiup) in 2005,” says Georgianna Bell, executive director of the Restless Legs Syndrome Foundation, which is funded by drugmakers Glaxo and Boehringer Ingelheim.

If the generic switch leads to fewer ads, that should decrease patient demand for diagnosis and treatment, leaving only the most serious sufferers to weigh the benefits of the drugs against the risks of potentially severe side effects, MSNBC writes.

Whether the ads decline depends largely on the makers of Mirapex, the second-leading drug approved to treat restless legs syndrome, according to Lisa Schwartz, associate professor of medicine and community and family medicine at Dartmouth Medical School. “If it ends up that they pull back, the market might go down,” she tells MSNBC. A Boehringer spokesman declined to comment.

“This is going to be an interesting transition to follow. Folks may not be asking their docs for the once-highly-advertised drug to treat the leg twitch they were led to believe was a disease worthy of drug treatment,” Gary Schwitzer, an associate professor in the University of Minnesota School of Journalism and Mass Communication, writes to MSNBC. Doctors may not be inclined to prescribe a drug if the supply of brand-name samples disappears. And the generics won’t come with samples, he notes.

Requip had sales of $213,127,000 in 2008.

While restless leg syndrome may fade into oblivion without drug company funded promotion, Glaxo has already hedged its bet by reformulating an extended release version of Requip, Requip XL, with a fresh new patent for the treatment of Parkinson's disease.

Even so,  Glaxo is trying to keep its RLS franchise alive. A new drug, Horizant, has been submitted to the FDA for approval for RLS. But this week, the FDA informed them that the drug doesn’t pass muster due to a preclinical finding of pancreatic cell tumors found in rats (statement).

Wall Street forecasts called for $500 million or more in annual sales, but it now appears additional study work may be needed.

Drug makers claim that  up to 8 million people in the US suffer from the problem, although there has been controversy over reports that the disorder is exaggerated.