Research Shows Rasagiline Reduces “OFF” Time
HELSINKI, FINLAND — (MARKET WIRE) — 09/04/2003 — Rasagiline added to levodopa therapy reduced the total time when Parkinson’s symptoms are not adequately controlled (“off” time) by 1.2 hours daily or 21 percent, a significant portion of the day, according to an abstract presented at the 7th Conference of the European Federation of Neurological Societies (EFNS) in Helsinki.
“The data presented on rasagiline is good news for patients and neurologists. This treatment may offer the advantage of a well tolerated, once-daily therapy that reduces ‘off’ time and increases motor function,” said Dr. Warren Olanow, professor and chairman of the Department of Neurology at Mount Sinai School of Medicine.
The 18-week LARGO trial conducted in Europe, Israel, and Argentina included 687 patients and compared the effects of once-daily rasagiline to placebo and Comtan® (entacapone). As part of the trial, dosing of levodopa was optimized for each patient before initiation of treatment.
“Until now, many physicians would have been surprised that an MAO-B inhibitor would be potent enough to reduce ‘off’ time comparably to entacapone, but this study indicates that rasagiline may offer a new treatment alternative for adjunct therapy in this population,” said Dr. Olivier Rascol, lead author of the study. “I have great hope that rasagiline may help ease the burden of Parkinson’s disease for a broad spectrum of patients.”
Rasagiline significantly improved motor function and activities of daily living based on the Unified Parkinson’s Disease Rating Scale (UPDRS) in both the “on” and “off” states. The UPDRS measures a patient’s ability to perform simple motor tasks and activities of daily life. Comtan® taken with each dose of levodopa, improved the UPDRS scores similarly to rasagiline in the “on” state, but did not impact the UPDRS scores in the “off” state.
Patients who used rasagiline and those taking entacapone also experienced significant reductions in levodopa dose, even though the protocol restricted dosing adjustment to the first six weeks only. Patients who used rasagiline experienced side effects similar to those of patients using placebo. Adverse events more common with rasagiline than with placebo (at least 2% difference) included postural hypotension only.
The development of rasagiline — a novel, potent, selective, second-generation irreversible monoamine oxidase type B (MAO-B) inhibitor — is part of a long-term strategic alliance for global co-development and European marketing between Teva and H. Lundbeck A/S. Rasagiline was developed in cooperation between Teva and the Technion Research and Development Foundation.
A new drug application is expected to be submitted to the Food and Drug Administration (FDA) based on these and other trial results later this quarter.
Teva also anticipates submitting an application to market rasagiline as a treatment for PD in the European Union later this year.
Teva Neuroscience, Inc. and Eisai Inc. will co-promote rasagiline 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 Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 30 pharmaceutical companies in the world. Close to 90 percent of Teva’s sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva’s innovative R&D focuses on developing novel drugs for diseases of the central nervous system.
Teva Neuroscience, Inc. is a wholly owned 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 sales of nearly $1.5 billion in fiscal year 2002 (year ending March 31, 2003). Eisai focuses its efforts in four therapeutic areas: neurology, gastrointestinal disorders, oncology, and acute care.