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Tramiprosate for Alzheimer's Disease Gains Fast Track Status
Under the FDA Modernization Act of 1997, the Fast Track designation program is intended to facilitate the development and expedite review of drugs developed for the treatment of serious or life-threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition.
As previously announced, Neurochem requested a meeting with the FDA, which is now scheduled for August 2007 with the Division of Neurology Products. The goal of this meeting is to have a discussion on the tramiprosate (ALZHEMED(TM)) Phase III program and present an update on the work accomplished to date on the North American Phase III clinical trial. Neurochem will also seek FDA's feedback and validation on the next steps that would be acceptable to the agency especially with respect to the statistical models. In relation to the ongoing European Phase III clinical trial, patient screening activities will stop in August as Neurochem has exceeded its original patient enrolment objectives. However, in light of the information and experience gained from the North American Phase III clinical trial, Neurochem is presently considering modifications that would need to be made to the design of the European trial.