FDA approves non-injectable nasal glucagon for severe hypoglycemia

The first non-injectable glucagon therapy has been approved by the Food and Drug Administration (FDA) for emergency treatment of severe hypoglycemia. This therapy is a product of the pharmaceutical, Eli Lilly & Co. and will be sold under the name Baqsimi. Baqsimi is a nasal powder and has been approved for patients with diabetes who are 4 years and older. It will be available in a single-use dispenser containing a recommended dose of 3 mg.

For anyone who has had the displeasure of experiencing severe hypoglycemia or low blood glucose due to diabetes, knows all too well how stressful and scary the situation can be. Severe hypoglycemia is unpredictable and can happen anywhere at any time. Time is of the essence to administer glucagon, a hormone necessary to help raise a person’s severely low blood glucose to prevent coma or even death. While there currently is available powdered glucagon, to prepare it to give to someone with hypoglycemia, it involves a multistep system of mixing the powder and liquid in a vial, ready to inject. This often requires the person with diabetes having hypoglycemia to depend on assistance from family or friends who are willing and knowledgeable to prepare and administer glucagon by an injection.

Nasal glucagon is seen as a game-changing delivery method to replace the multistep system of mixing powder and liquid with a simple, 1-step spray. People living with diabetes are at risk of their blood sugar levels falling below the normal range. Normally glucagon is produced in the pancreas and works with insulin to regulate blood glucose levels in the body. Glucagon is released in the body when the blood glucose levels are low, signaling the liver to release glucose into the blood. If a person experiences hypoglycemia and if it becomes severely low, they may fall unconscious or be having a seizure and will be unable to eat or drink anything that has sugar or glucose in it to help bring up their glucose levels into a normal range. That is why an injection of glucagon prepared and delivered by someone else, has been needed to bring blood glucose levels back into balance.

With this new way of delivering glucagon to those with severe hypoglycemia, it is believed to simplify the current method, which can be critical to prevent death.

Baqsimi will be available in a single-use dispenser. Eli Lilly stated that the list price for a 1-pack of Baqsimi is $280.80; and a 2-pack is $561.60.

It is recommended that Baqsimi should not be given to patients with pheochromocytoma, a rare tumor of adrenal gland tissue, or by patients who have insulinoma, a tumor of the pancreas. Baqsimi should also not be taken by patients with a know hypersensitivity to glucagon or the inactive ingredients found in Baqsimi, as allergic reactions may occur. This drug also carries a warning for anyone who has been fasting for long periods, has adrenal insufficiency or has chronic hypoglycemia as these conditions could result in low levels of releasable glucose by the liver.

Common side effects from patients using Baqsimi have been nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes and itchiness.

It is hoped that with this approval of Baqsimi, that it will help people during times of severe hypoglycemia by easing the administration of using the simplicity of a nasal powder.