Agilect® Reduced Tremor and Severity of "Off" Time for Parkinson's sufferers
"Both of these sets of data add to the body of evidence that AGILECT® will be an important new treatment option for people living with PD," said Olivier Rascol, M.D., Ph.D., professor of pharmacology, University of Toulouse School of Medicine, Toulouse, France, and lead author of the poster detailing the analysis of tremor data and a contributing author of the severity of "off" time poster. "These data demonstrated that AGILECT® improved a common symptom and motor complications of moderate to advanced PD - tremor severity and 'off' time."
Additionally, other data have demonstrated a reduction of "off" time and improved patient performance in both the "on" and "off" states in patients using AGILECT®.
The findings from these analyses of the LARGO trial data were presented this week at the European Federation of Neurological Societies (EFNS) annual meeting. LARGO stands for "Lasting effect in Adjunct therapy with Rasagiline Given Once daily." The LARGO trial, conducted in Europe, Israel and Argentina, compared the effects of once-daily AGILECT® (1 mg) or entacapone (200 mg with each dose of levodopa) or placebo added to optimized levodopa and other concomitant PD therapy in PD patients experiencing significant daily motor fluctuations. In addition to optimized levodopa therapy, approximately 60 percent of patients in this study were also taking a dopamine agonist.
A post-hoc analysis evaluated the impact of AGILECT® (rasagiline mesylate) on tremor - a common PD symptom. Overall, patients who used AGILECT® experienced a significant reduction in tremor, using the tremor subscale score of the Unified Parkinson's Disease Rating Scale (UPDRS). The UPDRS includes measures such as a patient's ability to perform simple motor tasks and activities of daily living. Furthermore, in the subgroup of patients with severe tremor, those taking AGILECT® significantly improved by 4.18 points, from baseline (p=0.022) versus 2.16 points for placebo. Patients using entacapone in addition to levodopa experienced comparable improvements.
In the severity of "off" time substudy presented at EFNS, patients who used AGILECT® experienced a significant reduction (improvement) in their mean score on the motor subscale of the UPDRS in the "off" state of 4.38 units (p=0.013) compared to 1.95 (p=0.139) units with entacapone. Placebo increased the motor subscale score by 1.27 units, reflecting a worsening of severity of "off" time. The motor subscale measures a patient's motor functioning during periods of "off" time when levodopa is not working for these patients. The data show that in the "off" state, rasagiline provided significant improvement of PD motor symptoms, whereas entacapone did not.
These findings suggest a continuous effect of AGILECT® throughout the day and night - of particular importance to PD patients receiving levodopa who suffer from significant daily motor fluctuations, one of the more troubling complications of disease progression and prolonged levodopa therapy.
Patients who used AGILECT® experienced side effects similar to those of patients using placebo. The only adverse events more common with rasagiline than with placebo (at least 2 percent difference) was postural hypotension (dizziness upon standing).
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 the disease, which usually affects people over the age of 50.
AGILECT® (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® 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® as a monotherapy in early PD and as an adjunct to levodopa in moderate to advanced disease.
Teva Neuroscience, Inc. and Eisai Inc. will co-promote AGILECT® 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. Teva and H. Lundbeck A/S will co-promote the product in Europe, once approved there.
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), 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. 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 was also submitted for review in Canada Sept. 24, 2003, where, upon approval, it will be marketed by Teva Neuroscience, Inc.
AGILECT® (rasagiline mesylate) is registered trademark of Teva Pharmaceutical Industries, Ltd.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995 This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's and Eisai's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's and Eisai's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's or Eisai's ability to rapidly integrate the operations of acquired businesses, including Teva's recent acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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Tremor Agilect redusã ºi severitatea "Dezactivat" Timpul pentru Parkinson suferinzi - Agilect® Reduced Tremor and Severity of "Off" Time for Parkinson's sufferers - articole medicale engleza - startsanatate