SYMLIN® (pramlintide acetate) injection was approved by the U.S. Food and Drug Administration on March 16, 2005. SYMLIN is given at mealtime and is indicated for: Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy.

About SYMLIN

SYMLIN is an antihyperglycemic drug for use in patients with diabetes treated with insulin. SYMLIN is a synthetic analog of human amylin, a naturally occurring hormone that is made in the beta cells of the pancreas, the same cells that make insulin. In patients with type 2 diabetes who use insulin, and in patients with type 1 diabetes, those cells in the pancreas are either damaged or destroyed, resulting in reduced secretion of both insulin and amylin after meals. The use of SYMLIN contributes to glucose control after meals.

Clinical studies demonstrate that SYMLIN, a self-administered injection given prior to meals, helps patients achieve lower blood glucose (sugar) after meals, leading to less fluctuation during the day, and better long-term glucose control (A1C) compared to patients taking insulin alone. On average, patients in these studies used less mealtime insulin and also had a reduction in body weight compared to patients taking insulin alone. SYMLIN was studied in over 5300 individuals in the clinical program that led to approval.

Important safety information

SYMLIN is not intended for all patients with diabetes. SYMLIN is used with insulin and has been associated with an increased risk of insulin-induced severe hypoglycemia, particularly in patients with type 1 diabetes. When severe hypoglycemia associated with SYMLIN use occurs, it is seen within 3 hours following a SYMLIN injection. If severe hypoglycemia occurs while operating a motor vehicle, heavy machinery, or while engaging in other high-risk activities, serious injuries may occur. Appropriate patient selection, careful patient instruction, and insulin dose adjustments are critical elements for reducing this risk. This information is highlighted in a boxed warning in the SYMLIN prescribing information for health professionals and in a Medication Guide for patients, which will be distributed by pharmacists.

Other adverse events commonly associated with SYMLIN when co-administered with insulin were mostly gastrointestinal in nature, including nausea, which was the most frequently reported. The incidence of nausea was higher at the beginning of SYMLIN treatment and decreased with time in most patients. The incidence and severity of nausea are reduced when SYMLIN is gradually titrated to the recommended doses.

Healthcare professionals and people with diabetes may obtain more information, including the complete prescribing information and the medication guide, at www.SYMLIN.com.

About the hormone amylin

The hormone amylin is made in and secreted from the same cells in the pancreas that make and secrete insulin. These pancreatic cells are called beta cells. Amylin and insulin work together with another hormone, glucagon, to maintain normal glucose concentrations. Insulin and amylin concentrations normally increase while glucagon levels decrease after meals. Amylin helps suppress glucagon secretion.

About Diabetes

Diabetes affects an estimated 194 million adults worldwide and more than 18 million people in the United States. Approximately 4.5 million of these people in the United States are using insulin to treat their diabetes, one million people with type 1 diabetes and 3.5 million with type 2 diabetes. This population currently has limited therapeutic options. Patients with type 1 diabetes have complete beta cell deficiency and generally must use insulin to sustain life. Patients with type 2 diabetes who have progressed to insulin therapy have typically exhausted other therapeutic options for improved blood glucose control due to advanced beta cell dysfunction.