FDA APPROVES BOEHRINGER'S MIRAPEX FOR RESTLESS LEGS SYNDROME

Boehringer Ingelheim announced that the FDA has approved Mirapex (pramipexole dihydrochloride) tablets for the treatment of moderate to severe primary restless legs syndrome (RLS). RLS is a neurological sensorimotor disorder. Up to 10 percent of the U.S. adult population is affected by RLS, according to the company.

For the treatment of RLS, Mirapex is approved in varying doses and should be taken once daily two to three hours before bedtime. Mirapex was previously approved to treat the signs and symptoms of idiopathic Parkinson's disease.

The approval for RLS was based on safety and efficacy data from four randomized, double-blind, placebo-controlled clinical trials involving approximately 1,000 patients with moderate to severe RLS who were administered Mirapex (0.125, 0.25, 0.5 and 0.75 mg) or placebo once daily, two to three hours before going to bed. Patients taking Mirapex experienced statistically and clinically significant improvements in short- and long-term efficacy versus placebo. In three clinical studies, the mean change from baseline in total International RLS Rating (IRLS) scores for patients treated with Mirapex demonstrated a statistically significant greater improvement compared with placebo-treated patients. In a fourth study, efficacy was sustained with Mirapex over a period of nine months, including a six-month open-label treatment period followed by a 12-week placebo-controlled withdrawal period.

Approximately 9.1 million prescriptions for Mirapex have been written in the U.S. since its launch in 1997, according to Boehringer. The drug may cause patients to fall asleep without any warning, even while doing normal daily activities such as driving, the company said.