FDA Approves First Non-Injection Glucagon Therapy for Severe Hypoglycemia

The FDA has approved Baqsimi nasal powder, the first glucagon therapy for the emergency treatment of severe hypoglycemia that can be administered without an injection.

The powder, which will be administered nasally and come in a single-use dispenser, increases blood sugar levels in patients experiencing severe hypoglycemic episodes.

The safety and efficacy of the nasal powder was evaluated in 2 studies involving 83 and 70 adult patients with diabetes and 1 study of 48 children with diabetes over the age of 4 years with type 1 diabetes. The studies compared a single dose of Baqsimi to a single dose of injectable glucagon. Overall, Baqsimi was shown to adequately increase blood sugar levels.

The most common adverse reactions associated with Baqsimi are nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes and itchiness.

—Michael Potts

Reference:

FDA approves first treatment for severe hypoglycemia that can be administered without an injection [press release]. July 24, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection.