Case Evaluation

Mirapex: FDA Approves Mirapex for Restless Legs Syndrome

FDA approves MIRAPEX for the treatment of moderate-to-severe primary Restless Legs Syndrome

RIDGEFIELD, CT, November 10, 2006 - Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex® (pramipexole dihydrochloride) tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). RLS is a common, yet often undiagnosed, neurological sensorimotor disorder. While symptoms can vary from person to person, they are typically described as an urge to move the legs accompanied by burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. Symptoms begin or worsen during periods of rest or inactivity – for example, when lying down or sitting in a movie – and generally are worse at night. Up to ten percent of the U.S. adult population is affected by RLS.

“RLS patients may experience daytime tiredness, mood disturbance, and an impaired ability to perform daily activities,” said Professor John W. Winkelman, MD, PhD, Medical Director of the Sleep Health Center of Brigham and Women’s Hospital, Boston, Massachusetts. “Oftentimes sufferers don’t realize that they have an underlying treatable medical condition that is causing these symptoms as well as sleep disturbance. With MIRAPEX, physicians now have another option to help manage their patients’ RLS symptoms.” For the treatment of RLS, MIRAPEX is approved in varying doses and should be taken once daily 2-3 hours before bedtime. MIRAPEX is also approved to treat the signs and symptoms of idiopathic Parkinson’s disease, and is supported by nearly a decade of real-world experience in the treatment of Parkinson’s disease.

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