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Levodopa/Carbidopa Intestinal Gel for Advanced Parkinson's Disease Receives Fast Track Desigation
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.
"We 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 population," 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 Parkinson's disease. Orphan Drug designation provides seven years of marketing exclusivity from the date of a drug’s 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.
For information about clinical trial registration, please visit www.clinicaltrials.gov.
About Advanced Parkinson’s disease
Parkinson’s disease is a progressive, neurodegenerative disorder that impairs mobility and control of movement. The disorder is caused by loss of dopamine-containing neurons in the substantia nigra area of the brain. Characteristic features include resting tremor, rigidity, bradykinetic (slow) movements and instability of posture. Levodopa is the standard treatment for the management of motor symptoms and has been shown to improve patient mobility and reduce disability. However, patients in the advanced stage of Parkinson’s disease who have been treated with oral levodopa for several years may develop severe fluctuations in motor control characterized by unpredictable swings between mobility and immobility (“on-off” phenomenon).
About Levodopa/carbidopa intestinal gel
For long-term administration, the levodopa/carbidopa intestinal gel should be delivered by a portable pump directly into the duodenum through a tube inserted via percutaneous endoscopic gastrostomy (PEG) with an outer transabdominal tube and an inner intestinal tube. The pump used in the Phase III clinical studies is the Smiths Medical CADD-Legacy® 1400 ambulatory pump.
Levodopa/carbidopa intestinal gel is currently not approved by the FDA. It is registered in the entire European Economic Area (EEA) under the trade name Duodopa™. Marketing authorizations outside the EEA have been granted in Australia, Canada, Croatia and Switzerland. Orphan drug status was obtained in the European Union in 2001 and in Australia in 2006.
Source: Solvay Pharmaceuticals