The glucose-lowering drug pramlintide will now be available in pens, but not for patients not using premeal bolus insulin.
Last month the Food and Drug Administration said Amylin could begin marketing the SymlinPen 60 and the SymlinPen 120 pen-injector devices for administering pramlintide injection, currently sold in vials. The pens are expected to be available by December 2007, the firm said.
Dosing had been an issue with the vials due to confusion with insulin syringes, which are not marked in microgram units. But the SymlinPen 60 delivers fixed doses of 15, 30, 45, or 60 mcg; the SymlinPen 120 delivers only 60- and 120-mcg doses.
The agency also issued a “Not Approvable” letter for those using only basal insulin without concurrent mealtime (bolus) insulin. Supporting data included results from a 16-week, double-blind, placebo-controlled study of 212 patients with type 2 diabetes who used glargine (basal) insulin with or without oral antidiabetic agents, but who did not use premeal insulin (Diabetes Care 2007 Aug. 13 [Epub ahead of print]). In those completing the study, hemoglobin A1c reductions from baseline were greater in the 87 on pramlintide (7.8%, from 8.5%), compared with the 91 on placebo (8.1%, from 8.5%), said Dr. Matthew Riddle, of Oregon Health and Science University, Portland, and associates. An FDA spokeswoman said the agency does not discuss its nonapprovable actions.