Needle-free Hypoglycemia Treatment Approved

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The FDA on Wednesday, July 24, 2019, announced approval of the first glucagon treatment to reverse severe hypoglycemia in persons with diabetes that is taken without an injection.

Hypoglycemia, generally defined as a blood glucose level <70 mg/dL, is considered a medical emergency and historically has been treated with powdered glucagon that must be reconstituted, requiring several steps before administration. Nasal glucagon, to be marketed by Eli Lilly as Baqsimi, is delivered as a dry powder spray in a portable, single-use, pre-assembled device.

The dry powder is released at the press of a small plunger at the bottom of the device after the caregiver inserts the device tip into a nostril. Absorption is through the nasal cavity lining and administration does not require the person to inhale or breathe deeply.

Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, notes in an FDA press release that the “… new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure." Woodcock adds that, given the need for immediate treatment for a patient with hypoglycemia, the process needs to be “as simple as possible."

Two of the 3 trials leading to approval were conducted in adults (N= 83 and N=70), the third in children (N=48, aged ≥ 4 years). In all trials a single dose of Baqsimi was compared to a single dose of injected glucagon in response to insulin-induced hypoglycemia. Baqsimi adequately increased blood glucose levels. Baqsimi is indicated to treat severe hypoglycemia in patients with diabetes aged ≥ 4 years.

Labeling includes contraindications to use of Baqsimi in people with pheochromocytoma, with insulinoma pancreatic tumors, and anyone with known hypersensitivity to glucagon. Also on the label are cautionary warnings for use in people who have been fasting, had adrenal insufficiency or chronic hypoglycemia.

Side effects of the nasal spray are similar to those of injectable glucagon and also include several unique to intranasal delivery, eg, watery eyes and nasal congestion

While a single episode of hypoglycemia is rarely fatal, repeated episodes can lead to “hypoglycemia unawareness,” increasing the potential for a life-threatening event. People with diabetes also may try to avoid “hypos” and voluntarily decrease insulin dose or other diabetes medications, placing them at risk of prolonged hyperglycemia and resultant diabetes complications.