Gvoke HypoPen: An Auto-Injector Containing an Innovative, Liquid-Stable Glucagon Formulation for Use in Severe Acute Hypoglycemia

Introduction

The use of insulin to decrease complications associated with diabetes currently focuses on attempts to control elevated glucose levels. This has often been balanced with a calculated risk potential for over-treatment and resultant hypoglycemia. This subsequent hypoglycemia can have a greater effect on morbidity and mortality for patients with type 1 diabetes, who are reliant on exogenous insulin, and extreme hypoglycemic events are directly associated with substantial overall health care costs (1). Current therapy for acute, severe hypoglycemia includes a glucagon emergency kit (GEK), which is effective when used correctly. However, training on how to appropriately assemble the GEK is rare, and administration of emergency glucagon can be complicated for the inexperienced.

Glucagon, a peptide hormone normally produced endogenously in the pancreas, acts as an agonist at the glucagon receptor, initiating a pathway resulting in the conversion of glycogen in the liver to the more accessible form of glucose that can be released into the blood. Exogenous glucagon is currently available in a powder that must be reconstituted in solution immediately before intramuscular or intravenous delivery due to its instability in solution (2,3 …