Approval was based on three studies two adult studies (roughly 150 patients) and a pediatric study (roughly 50 patients) that compared a single dose of glucagon powder to a dose of injection.
‘The FDA has approved a nasal powder in a single-use dispenser to treat severe hypoglycemia in patients with diabetes. ’
Efficacy and safety outcomes were similar across studies.
The drug carries a warning for patients who have conditions that might cause low levels of releasable glucose in the liver (adrenal insufficiency, chronic hypoglycemia, long periods of fasting).
Additionally, it shouldn't be given to patients with pancreatic or adrenal gland tissue tumors or sensitivities to the drug's ingredients.
Common side effects include headache, nasal congestion, nausea, upper respiratory tract irritation, vomiting, and watery eyes.
The list price for a single pack of Baqsimi is $280.80, according to the manufacturer.