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Progress in the Treatment and Understanding of Restless Legs Syndrome November 3, 2005
Decision Resources, Inc., Nov 2005, Pages: 17
Restless legs syndrome (RLS), a chronic and slowly progressing disease characterized by an irresistible urge to move the legs, is a poorly understood and underdiagnosed disease, even though it affects up to 20 million people in the United States alone. The symptoms of RLS can be painful, and because these symptoms are most likely to occur during sleep, they often result in extended periods of sleep deprivation. RLS is often treated through off-label prescriptions to control symptoms; the first agent specifically labeled for RLS was approved in May 2005, and new agents are being developed to treat the syndrome’s symptoms and improve the quality of life for patients.
This report describes recent advances in understanding of the causes of RLS, including its potential genetic component. We outline current therapies that are used (primarily off-label) to treat the symptoms of RLS as well as emerging therapies, including recently approved agents for this indication, and discuss how these new therapies may improve treatment. Finally, we discuss the current and future market for RLS and the opportunities and challenges for pharmaceutical companies looking to enter this arena.
Business Implications
- Recent epidemiology and genetic linkage studies confirm the fact that restless legs syndrome (RLS) is a distinct disease caused by genetic and neurosensory defects rather than psychological ones. In the coming years, RLS genes will be identified. This development will lead to a better understanding of the disease, as well as to better tests to diagnose RLS and to predict an individual’s susceptibility to developing it. These advances will drive increased use and sales of drugs capable of treating RLS.
- Many drugs in different classes are effective at some level in RLS. Dopamine agonists, the first-line of treatment for RLS, have been
shown to be particularly effective and will continue to be physicians’ first choice for the foreseeable future. However, antiepileptics and opioids have also shown their potential for use in advanced stages of disease with pain. Treatment with iron may be especially beneficial in those patients in whom iron deficiency may be causative, and iron supplement therapy may represent a potential cure for RLS.
- Despite the large potential market for RLS-specific drugs, the treatment armamentarium is likely to remain a mix of generic, off-label, reengineered, and RLS-approved drugs for the immediate future. This market scenario results from a well-established off-label market as well as from drugs going off-patent and being replaced by redesigned drugs or generics.
- Given the complex genetic pattern that research is continuing to reveal, it appears that there are several RLS genes that give rise to the disease. Many RLS-specific drug targets may exist, including dopamine receptors, dopamine transport proteins, ion channels, monoamine oxidase, and opioid receptors. We anticipate that several drugs will be successfully developed and approved for RLS over the next few years. The key will be to determine which patient will benefit from which drug and when.
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