AGILECT Improved Parkinson's Disease Symptoms Without Worsening Cognitive and Behavioral SymptomsData presented at Mental Dysfunction in
Parkinson's Disease Conference
KANSAS CITY, Mo. and TEANECK, N.J., October 27, 2004 /PRNewswire/ -- AGILECT(R) (rasagiline mesylate), 1 mg dosed once daily, improved symptoms of Parkinson's disease (PD), including motor fluctuations, without significantly increasing the occurrence of cognitive and behavioral adverse events (CBAE) in early and in moderate-to-advanced PD patients. Data from two pivotal studies were re-analyzed and demonstrated a low incidence of this type of adverse event with AGILECT(R) versus placebo. These results were presented at the Mental Dysfunction in Parkinson's Disease Conference in Salzburg, Austria.
Lawrence Elmer, M.D., Ph.D., director of the Center for Neurological Disorders and the Parkinson's Disease and Movement Disorder Program at the Medical College of Ohio presented the data on behalf of the Parkinson Study Group. "These results support the overall clinical utility we have seen with rasagiline in development trials," said Dr. Elmer. "Cognitive and behavioral issues can be common deterrents to effective management of Parkinson's disease. The low occurrence of cognitive and behavioral adverse events with rasagiline is encouraging."
Teva Neuroscience, Inc., and Eisai Inc. will co-promote AGILECT(R) in the United States, once approved by the FDA, as part of a long-term strategic alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd.
The analysis presented by Dr. Elmer evaluated the occurrence of CBAE and the change from baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I mental subscores from both a monotherapy and an adjunct therapy study. Part I of the UPDRS is the mental subscore that rates patients' intellectual impairment, thought disorders, depression and motivation/initiative.
The data demonstrated a low incidence of CBAE with AGILECT(R) (rasagiline mesylate), compared to placebo. The CBAE of hallucinations, confusion, depression, somnolence and other sleep disorders in the subjects treated with AGILECT(R) were few and did not exceed the incidence seen in subjects receiving placebo by more than 3 percent. In addition, UPDRS Part I mental subscores showed no significant difference in the changes from baseline between AGILECT(R) and placebo.
The data were taken from two pivotal studies that evaluated the safety and efficacy of AGILECT(R). The two studies, called TEMPO* and PRESTO*, included over 800 patients, and were conducted by the Parkinson Study Group. The TEMPO monotherapy trial enrolled patients with early-stage PD who were not receiving dopaminergic therapy. The PRESTO adjunct therapy trial included patients with moderate-to-advanced PD who were receiving optimized doses of levodopa, as well as other PD medications such as dopamine agonists and COMT inhibitors, and were still experiencing motor fluctuations.
"Rasagiline, given once daily, improved the patients' PD symptoms, but did not have observed effects on their mental functioning, behavior or mood," said Dr. Elmer. "This analysis of the clinical trials data suggests rasagiline may improve symptoms in PD without increasing cognitive and behavioral adverse events."
AGILECT(R) was well tolerated in both trials. In TEMPO, adverse events seen more frequently in the AGILECT(R) 1 mg group (frequency greater than 3 percent on treatment and at least 2 percent greater than placebo) were headache, dyspepsia, depression, flu syndrome and rash. In PRESTO, adverse events seen more frequently in the AGILECT(R)1 mg group (frequency greater than or equal to 6 percent on treatment and at least 2 percent greater than placebo) were dyskinesia, accidental injury, nausea, weight loss, constipation, postural hypotension, arthralgia, vomiting, dry mouth and rash.
Parkinson's disease is a degenerative disorder of the brain. Symptoms can include tremor, stiffness, slowness of movement and impaired balance. An estimated one million Americans have PD, which usually affects people over the age of 50.
The Parkinson Study Group (http://www.parkinson-study-group.org/) is a non-profit, cooperative group of PD experts from medical centers in the United States and Canada who are dedicated to improving treatment for persons affected by PD.
AGILECT(R) (rasagiline mesylate) is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a substance in the brain needed to facilitate movement. A new drug application for AGILECT(R) for the treatment of PD was submitted to the U.S. Food and Drug Administration (FDA) Sept. 5, 2003. Indications are being sought for once-daily AGILECT(R) as a monotherapy in early PD and as an adjunct to levodopa in moderate to advanced disease.
Teva Pharmaceutical Industries Ltd. , headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Neuroscience, Inc. is a subsidiary of Teva Pharmaceutical Industries Ltd.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products in more than 30 countries. Established in 1995, Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with more than $1.7 billion in sales for fiscal year 2003 (year ending March 31, 2004). Eisai focuses its efforts in four therapeutic areas: neurology, gastrointestinal disorders, oncology and acute care.
The development of rasagiline is part of a long-term alliance for co-development in Parkinson's disease and European marketing between Teva and H. Lundbeck A/S. Teva and H. Lundbeck A/S will co-promote the product in Europe, once approved there. Rasagiline was developed cooperatively by Teva and the Technion -- Israel Institute of Technology.
Teva submitted an application to market rasagiline as a treatment for PD with the European Agency for Evaluation of Medicinal Products (EMEA) on Oct. 10, 2003.
Rasagiline also was submitted for review in Canada Sept. 24, 2003, where, upon approval, it will be marketed by Teva Neuroscience, Inc.
AGILECT(R) (rasagiline mesylate) is a registered trademark of Teva Pharmaceutical Industries Ltd.
* TEMPO TVP-1012 in Early Monotherapy for Parkinson's Disease Outpatients
* PRESTO Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off"
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