Once-Daily MIRAPEX ER Now Approved by FDA for Both Early and Advanced Parkinson's Disease

New treatment option for the nearly one million Americans affected by Parkinson's disease

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Boehringer Ingelheim Pharmaceuticals, Inc.

Mar 23, 2010, 09:36 ET

RIDGEFIELD, Conn., March 23 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily Mirapex ER® (pramipexole dihydrochloride) extended-release tablets for the signs and symptoms of idiopathic Parkinson's disease (PD), which includes early and advanced PD. PD is the second most common chronic neurological disorder in older adults after Alzheimer's. Parkinson's disease has no cure.

"In a pivotal trial of patients with advanced Parkinson's disease, MIRAPEX ER not only demonstrated significant symptom improvement, but also increased the number of hours during which people with advanced Parkinson's disease had better mobility," said Anthony Schapira, M.D., head of department and chairman of Clinical Neurosciences Specialties, The Institute of Neurology, University College London, London, UK. "With this approval, MIRAPEX ER may now help early as well as advanced PD patients with its convenient once-daily dosing schedule."

Study findings showed that patients with advanced PD who were treated with MIRAPEX ER experienced superior symptom relief versus placebo. In addition, MIRAPEX ER demonstrated benefits similar to Mirapex® (pramipexole dihydrochloride) tablets, each versus placebo. Treatment with MIRAPEX ER also resulted in significant reductions of off-time (period of time when symptoms return) versus placebo.

"With the approval of MIRAPEX ER, we are hopeful that this once-daily treatment option may help ease some of the burden and obstacles that people with advanced Parkinson's disease face on a daily basis," said Albert Ros, executive vice president, Boehringer Ingelheim Pharmaceuticals, Inc.

Clinical Trials

The FDA approval of MIRAPEX ER for advanced PD patients was supported by efficacy data from one randomized, double-blind, placebo-controlled, 3-parallel group clinical study. The clinical trial program involved 517 patients with advanced Parkinson's disease who were treated with varying doses of MIRAPEX ER, MIRAPEX or placebo. The primary efficacy outcome was the adjusted mean change from baseline to week 18 in Unified Parkinson's Disease Rating Scale (UPDRS) Parts II+III score with Part II averaged for on- and off-time and Part III assessed during on-time. The key secondary efficacy outcome was change in daily off-time at week 18. Maintenance of efficacy was analyzed at 33 weeks.

In the trial, superiority of MIRAPEX ER over placebo was demonstrated after 18 weeks of treatment, on both primary and key secondary efficacy endpoints. In addition, maintenance of efficacy was shown in patients who completed 33 weeks of treatment. In the study, MIRAPEX ER demonstrated similar benefits as MIRAPEX, each versus placebo, in people with advanced PD.

The most common adverse events (incidence greater than or equal to 5 percent and greater than placebo) in advanced PD concomitantly treated with levodopa were dyskinesia, nausea, constipation, hallucinations, headache, and anorexia.

*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 to treat the signs and symptoms of idiopathic Parkinson's disease, which includes early and advanced PD. 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 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.

The most common side effects in people taking MIRAPEX ER tablets for early PD are sleepiness, nausea and vomiting, constipation, dizziness, fatigue, hallucinations, dry mouth, muscle spasms, and edema (swelling of the feet and ankles). The most common side effects in people taking MIRAPEX ER tablets who have later-stage PD are abnormal movements, nausea, constipation, hallucinations, headache, and anorexia.

The most common side effects in people taking MIRAPEX for PD are nausea, dizziness, sleepiness, constipation, hallucinations, insomnia, muscle weakness, confusion, and abnormal movements.

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.