Amylin Symlin dose titration trial
Executive Summary
Amylin will submit results of a dose titration study for Symlin in 250 type-1 diabetes patients as an amendment to its NDA in the second-half of 2002. Patients will be followed for six months after a one month period of pramlintide titration; insulin adjustments will be allowed throughout the study, as requested by FDA's Endocrinologic & Metabolic Drugs Advisory Committee July 26 (1"The Pink Sheet" July 30, 2001, p. 5). The dosing data is expected to be included in labeling. Amylin is also conducting short pharmacokinetic and pharmacodynamic trials. Symlin received an "approvable" letter Oct. 12 requesting additional clinical data (2"The Pink Sheet" Oct. 15, 2001, In Brief)...