FDA Approves Once-Daily MIRAPEX ER for the Treatment of Early Parkinson's Disease

RIDGEFIELD, Conn., Feb. 22 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved Mirapex ER® (pramipexole dihydrochloride) extended-release tablets, a new once-daily treatment option for the signs and symptoms of early idiopathic Parkinson's disease (PD). MIRAPEX ER is not indicated in advanced PD. Parkinson's disease is a chronic, slowly progressive and potentially debilitating neurological condition affecting nearly one million people in the U.S., with one person newly diagnosed every nine minutes.

"MIRAPEX ER for early Parkinson's disease is a positive development in the treatment of this disease. This new, once-daily treatment has a more convenient dosing schedule, offering greater flexibility as someone with early Parkinson's disease plans his or her day," said Robert Hauser, M.D., professor of Neurology, and director, Parkinson's Disease & Movement Disorders Center at the University of South Florida College of Medicine. "In general, patients often prefer once-daily dosing to a more frequent regimen because of convenience."

Findings from clinical studies show MIRAPEX ER to be superior to placebo and with benefits comparable to the currently available immediate-release MIRAPEX in early Parkinson's disease. More than twelve years of real-world experience supports the use of pramipexole in the treatment of Parkinson's disease.

"We are committed to providing effective treatment options that may help ease the burden of Parkinson's disease, and the MIRAPEX ER approval is very exciting," said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc. "The Parkinson's community now has an important new treatment option with benefits similar to the currently available immediate-release formulation."

Clinical Trials

The FDA approval was supported by clinical pharmacokinetic data, and by a single randomized, double-blind, placebo-controlled multicenter clinical trial. A second study evaluated an overnight switch from MIRAPEX to MIRAPEX ER. The clinical trial program involved more than 400 patients with early Parkinson's disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo and assessed after periods of nine weeks and 18 weeks. The first study, conducted in people with early Parkinson's disease, compared MIRAPEX ER and MIRAPEX, each versus placebo. Patients treated with MIRAPEX ER experienced clinically significant symptom relief, as measured by mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS)* II+III score, compared with placebo. A second study evaluated the efficacy of an overnight switch from MIRAPEX to MIRAPEX ER. Eighty-five percent (87 of 104) of patients who completed the trial were successfully switched to MIRAPEX ER. Some patients required dose adjustments.

Early Parkinson's disease Clinical Highlights:

• Patients with early PD who were treated with MIRAPEX ER showed clinically significant improvement in symptoms after 18 weeks compared to placebo. In the same study, MIRAPEX-treated patients experienced similar clinically significant improvements, compared to placebo.
  • After 18 weeks, patients treated with MIRAPEX ER experienced statistically significant improvement versus placebo in UPDRS II+III score.
• In a nine-week study, the majority of early PD patients treated with MIRAPEX were successfully switched overnight to MIRAPEX ER.
  • Patients treated with MIRAPEX were randomized overnight to MIRAPEX ER or to MIRAPEX. Primary efficacy endpoint was the proportion of patients successfully switched (no worsening of UPDRS II+III >15 percent from baseline and no drug-related adverse event leading to withdrawal) to MIRAPEX ER. More than 95 percent of patients completed the trial. Eighty-five percent (87 of 104 patients) were successfully switched (some patients required dose adjustments) to the once-daily formulation. These data support a 1:1 switch from MIRAPEX to MIRAPEX ER for most patients.
• In both of the studies, the safety and tolerability profile of MIRAPEX ER in patients with early PD was similar to that of MIRAPEX when each was compared with placebo.

*The Unified Parkinson's Disease Rating Scale (UPDRS)

The Unified Parkinson's Disease Rating Scale (UPDRS) is a comprehensive tool, which was developed to follow the longitudinal course of PD-related disability and impairment. The UPDRS II+III score was used as the primary efficacy endpoint in clinical trials. UPDRS Part II relates to activities of daily living and UPDRS Part III relates to motor symptoms. The UPDRS II+III score ranges from 0 (no disability) to 160 (worst disability).

About Parkinson's disease

Parkinson's disease is a progressive neurological disorder that affects nearly one million people in the U.S. It is the second most common chronic neurological disorder in older adults after Alzheimer's. Every nine minutes someone is diagnosed with Parkinson's disease. Symptoms include tremor, muscle rigidity, slowed motion, shuffling gait, and a loss of facial expression. The symptoms vary from individual to individual, but become more severe over time. Although promising research is being conducted, there is currently no cure for Parkinson's disease.

About Mirapex® (pramipexole dihydrochloride) tablets and Mirapex ER® (pramipexole dihydrochloride) extended-release tablets

MIRAPEX is indicated in the U.S. for the treatment of the signs and symptoms of idiopathic Parkinson's disease in a three times daily immediate-release formulation. MIRAPEX ER is now approved in a once-daily, extended-release formulation for early Parkinson's disease. MIRAPEX is supported by more than twelve years of real-world experience in the treatment of Parkinson's disease, with more than 16 million prescriptions written in the U.S. since its launch in 1997.

MIRAPEX ER is not indicated for advanced Parkinson's disease or for the treatment of restless legs syndrome (RLS).

Important Safety Information:

MIRAPEX ER and MIRAPEX may cause you to fall asleep while you are doing daily activities such as driving, talking with other people, or eating. Talk to your doctor if you drink alcohol or take other medications that make you drowsy, as these can increase the chance that MIRAPEX ER or MIRAPEX will make you feel sleepy or fall asleep when you should be awake. When taking MIRAPEX ER or MIRAPEX, hallucinations (unreal visions, sounds or sensations) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly.

In a clinical trial for early Parkinson's disease (PD), the most commonly reported side effects of MIRAPEX ER that were more frequent than with placebo are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles).

In clinical trials for early PD, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea, dizziness, sleepiness, difficulty falling asleep, weakness, and constipation.

Some patients taking certain medicines to treat PD, including MIRAPEX ER and MIRAPEX, have reported problems such as gambling, compulsive eating, compulsive buying and increased sex drive. If you or your family members notice that you are developing unusual urges or behaviors, talk to your doctor.

For full MIRAPEX ER or MIRAPEX prescribing information, please contact Boehringer Ingelheim's Drug Information Unit at 1-800-542-6257.

Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2008, Boehringer Ingelheim posted net sales of US $17 billion (11.6 billion euro) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.

For more information, please visit http://us.boehringer-ingelheim.com.

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.