The FDA has approved the first treatment for severe hypoglycemia that can be administered without an injection, the agency announced on July 24.
Glucagon (Baqsimi) nasal powder, which comes in a single-use dispenser, is indicated for the emergency treatment of severe hypoglycemia in patients with diabetes ages 4 years and older. Two studies of 83 and 70 adults with diabetes compared the effect of a single dose of the powder versus a single dose of glucagon injection on insulin-induced hypoglycemia, and the powder adequately increased blood glucose levels. Similar results were observed in a pediatric study of 48 patients over the age of 4 years with type 1 diabetes.
The drug is contraindicated in patients with pheochromocytoma or insulinoma. It carries a warning that it should be used with caution by those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia. The most common adverse reactions were nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. Side effects are similar to those of injectable glucagon, with the addition of nasal and eye-related symptoms (e.g., nasal congestion, watery eyes).