The Chicago-based company’s rescue pen is under review for approval by the FDA as a treatment for severe hypoglycemia in people with diabetes.
“Hypoglycemia can quickly evolve from a mild event to an emergency, so prompt and reliable intervention is critically important. Robust research supports our investigational ready-to-use liquid glucagon pen as an effective, user-friendly alternative to currently marketed products,” chairman & CEO Paul Edick said in prepared remarks. “On the heels of our recent regulatory filing, we are now actively working toward our goal of introducing this important innovation to the diabetes community.”
In one Phase III trial, researchers compared the Xeris glucagon pen to a commercially-available glucagon emergency kit (GEK) to treat severe hypoglycemia in 81 adults with Type 1 diabetes.
Xeris’ glucagon pen was able to more quickly resolve global symptoms of hypoglycemia, the company touted – 11.6 minutes compared to 13.1 minutes for the GEK.
In a separate usability study, 14 of 16 participants successfully administered a complete injection using Xeris’ glucagon pen compared to just 5 of 16 for the GEK. In a validation study among 75 adults, 98.7% of participants successfully used the glucagon pen.
Across all of the data presented at the 18th Annual Diabetes Technology meeting, Xeris noted that its device was safe and effective for those who were familiar and unfamiliar to using the pen.