Baqsimi, a nasal powder for the emergency treatment of severe hypoglycemia, has received the approval of the U.S. Food and Drug Administration.
This is the first and only glucagon therapy for severe hypoglycemia to be administered without injection.
Giving The Public More Option
"People who are living with diabetes are at risk of their blood sugar levels falling below the normal range," stated Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research, in a press release published on Wednesday, July 24. " There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process."
Hypoglycemia occurs when the blood sugar level of a patient, often a diabetic, falls below normal. This causes the patient to experience symptoms such as confusion, lightheadedness, blurred vision, trouble concentrating, fast or irregular heartbeat. Hypoglycemia might also cause seizures or convulsions and unconsciousness.
How To Use
Baqsimi by Eli Lilly and Company is administered into the nose through a single-use dispenser during a severe hypoglycemic episode. According to the announcement made by the FDA, the treatment works by stimulating the liver to release stored glucose into the bloodstream, raising the blood sugar level of the patient.
Baqsimi has been approved for use in patients with diabetes from agest 4 and up. The treatment, however, should not be used by patients who have pheochromocytoma (tumor of the adrenal gland tissue) or insulinoma (tumor of the pancreas). The drug contains glucagon as an inactive ingredient and, therefore, might cause an allergic reaction to some.
The FDA also warned those who have been fasting for long periods, have adrenal insufficiency, or have chronic hypoglycemia to use this treatment with caution.
Adverse reaction from taking Baqsimi includes headache, nausea, vomiting, watery eyes, redness of the eyes, and upper respiratory tract irritation.
The safety and efficacy of Baqsimi were evaluated in two studies that involved adults with diabetes. In both studies, administration of Baqsimi resulted to an increase in blood sugar levels. The result of a similar study involving younger patients has the same positive outcome.