Dear Arthritis Advisory Committee Members and Consultants:
It is my pleasure to invite you to participate in the FDA
advisory committee meeting on June 2 and 3, 2004. Discussions over these two days will be
focused on potential clinical trial designs and endpoints for the treatment of
acute and chronic gout.
On June 2, you will be discussing the appropriate design of
trials to demonstrate both efficacy and safety of new therapies for treatment
of hyperuricemia associated with chronic gout.
The discussion will include a specific NDA application for this
indication.
On June 3, we will be exploring clinical trial designs for
the treatment of acute gout. As
individuals with acute gout often experience significant pain, it will be
important to discuss potential pain based endpoints, along with other efficacy
and safety endpoints. The presentation
of a potential new therapy for this indication will be used as an example to stimulate
discussion.
We are looking forward to seeing you on June 2 and 3 at the
Advisory Committee Meeting Conference Room,
Sincerely,
Brian E. Harvey, M.D.,
Ph.D.
Acting Director
Division of Anti-Inflammatory, Analgesic
and Ophthalmic Drug Products, HFD-550
Office of Drug Evaluation V
Center for Drug Evaluation and Research