Solvay Pharmaceuticals, Inc. said the US Food and Drug Administration (FDA) has granted Fast Track designation to the development programme for levodopa/carbidopa intestinal gel for the potential long-term treatment of motor fluctuations associated with advanced Parkinson's 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. 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 is the time the FDA takes 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 enrol patients in pivotal studies in the US and Germany this summer, the company said.
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.