FDA approves noninjectable therapy for hypoglycemia

The US Food and Drug Administration (FDA) has given approval to the first glucagon therapy for severe hypoglycemia in patients with type 1 diabetes that can be administered directly into the nose rather than by injection.

Baqsimi (Eli Lilly and Co., Indianapolis, Indiana) nasal powder comes in a single-dose dispenser that eliminates the need to mix a glucagon injection and enables immediate administration for severe hypoglycemia in an emergency situation. The drug increases blood sugar levels in the body by stimulating the liver to release stored glucose into the bloodstream. This is opposite the effect of insulin, which reduces blood sugar levels.

Efficacy and safety of Baqsimi were evaluated in 2 studies of 83 and 87 adults with type 1 diabetes. The studies compared a single dose of Baqsimi to a single dose of glucagon injection in causing a blood sugar response to insulin-reduced hypoglycemia. In both studies, Baqsimi increased the blood sugar levels of the participants. Similar results were achieved in a pediatric study of 48 children aged 4 years and older with type 1 diabetes.

The new antihypoglycemic agent should not be used by patients with pheochromocytoma, a rare tumor of the kidneys or adrenal gland, or insulinoma, a tumor in the pancreas. Baqsimi should not be taken by anyone who is allergic to glucagon or its inactive ingredients, betadex and dodecylphosphocholine. The drug carries a warning that it should not be used by patients who have been fasting for prolonged periods or who have adrenal insufficiency or chronic hypoglycemia because these conditions cause low levels of releasable glucose in the liver.

In addition, Baqsimi should not be taken by women who are breastfeeding or plan to breastfeed because it is not known if glucagon crosses into breast milk.

Most common adverse reactions are nausea, vomiting, headaches, and upper respiratory tract infection, all similar to injectable glucagon. Patients with adrenal gland tumors treated with Baqsimi may experience spikes in blood pressure, and those with pancreatic tumors may experience low blood sugar. Also, nasal congestion, watery red eyes, and itchiness of eyes, nose, and throat may occur because the drug is administered intranasally.

The FDA cautions that patients who receive Baqsimi and caregivers who administer the drug should contact emergency medical assistance immediately after use and also notify the patient’s healthcare provider.