Solvay Pharmaceuticals, Inc. Receives Fast Track Designation From U.S. Food and Drug Administration for Levodopa/Carbidopa Intestinal Gel for Advanced Parkinsonís Disease
Solvay Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for levodopa/carbidopa intestinal gel for the potential long-term treatment of motor fluctuations associated with advanced Parkinsonís disease.
Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients. In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review means that the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.
ďWe are very pleased that the FDA has granted levodopa/carbidopa intestinal gel Fast Track designation and believe that it will be of great assistance in our efforts to expeditiously bring a new treatment option to this important and underserved advanced-stage patient populationĒ said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc.
In 2000, levodopa/carbidopa intestinal gel received Orphan Drug designation from the FDA for the treatment of late-stage Parkinsonís disease. Orphan Drug designation provides seven years of marketing exclusivity from the date of a drugís approval. In addition, user fees are waived and the sponsor is eligible for tax credits for clinical testing.
Solvay Pharmaceuticals is currently investigating levodopa/carbidopa intestinal gel in a global Phase III open-label safety study and will enroll patients in pivotal studies in the U.S. and Germany this summer.
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