FDA Approves First Nasally Administered Drug for Severe Hypoglycemia

Highlights:

FDA has approved a drug called Baqsimi^™ for treating severe hypoglycemia
It is the first drug for the treatment of severe hypoglycemia without the need for an injection
It is administered nasally and its efficacy is as good as injectable glucagon, which is conventionally used for treating severe hypoglycemia

FDA has approved the first drug for treating severe hypoglycemia (very low blood sugar) that can be delivered without an injection. The drug, Baqsimi^™, is a powdered form of glucagon for nasal administration. This is the first and only nasally administered glucagon for treating severe hypoglycemia.

The United States Food and Drug Administration (USFDA) has licensed the drug to Eli Lilly and Company, an American pharmaceutical company headquartered in Indianapolis, Indiana, USA.

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‘FDA has approved a drug for the treatment of severe hypoglycemia that can be administered without an injection. The drug, Baqsimi^™, is delivered nasally and results in rapid elevation of blood sugar levels.’
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What are the Dangers of Hypoglycemia?

Hypoglycemia is a condition that occurs primarily in diabetic patients that is characterized by a rapid fall in blood sugar levels below the normal range. Hypoglycemia is a medical emergency in patients with Type-1 or Type-2 diabetes. The hallmarks of hypoglycemia are altered mental and/or physical functioning, which requires immediate medical attention for recovery. In the absence of prompt treatment, it can lead to potentially life-threatening complications such as loss of consciousness, seizures, coma and even death.

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Presentation and Indications for the Use of Baqsimi^™

Baqsimi^™ is available as a compact, portable, ready-to-use pack that doesn’t require to be reconstituted. It has a single fixed dose of 3 mg powdered glucagon in the form of a nasal spray. The drug is absorbed directly through the nasal mucosa and therefore doesn’t need to be inhaled. Also, it doesn’t need to be refrigerated and can be kept at ambient temperatures (~30ºC). Baqsimi^™is recommended in severe cases of hypoglycemia in diabetic adults and children aged 4 years and above.

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Mechanism of Action of Baqsimi^™

Baqsimi^™works by stimulating the liver to release stored glucose into the bloodstream, which increases the blood sugar level. Its mechanism of action involves binding of glucagon with the glucagon receptors present in the liver. This stimulates gluconeogenesis, which is a metabolic process in which glucose is synthesized from non-carbohydrate precursors such as lactate, pyruvate and glucogenic amino acids. This newly synthesized glucose is rapidly released from the liver, thereby raising the blood sugar levels. This is essentially the exact opposite action of insulin, which lowers blood sugar levels.

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Advantages of Baqsimi^™

Baqsimi^™ has several advantages over injectable glucagon, which was approved by the USFDA way back in 1960. These advantages are well articulated by Dr. Janet Woodcock, MD, who is the Director of USFDA’s Center for Drug Evaluation and Research (CDER) at Silver Springs, Maryland, USA.

“People who are living with diabetes are at risk of their blood sugar levels falling below the normal range. 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,” said Woodcock. “This 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 maybe having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible.”

Clinical Trials of Baqsimi^™

Clinical trials were carried out both in adults and children, which are briefly highlighted below:

Adult Clinical Trials: Two clinical trials were carried out in adults, which included 83 and 70 adults, respectively. The safety and efficacy of Baqsimi^™ nasal powder were evaluated head-to-head against injectable glucagon for treating insulin-induced hypoglycemia, using a single dose of each drug. Baqsimi^™exhibited comparable efficacy to injectable glucagon in adults, with a 100 percent success rate in case of both drug formulations. The incidence of side-effects, which included headache, nausea, vomiting, and upper respiratory tract irritation, were similar in both cases.

Pediatric Clinical Trials: A clinical trial was carried out in children aged 4 years to <17 years. The clinical trial compared the safety and efficacy of Baqsimi^™ and injectable glucagon. Both drugs exhibited a 100 percent success rate in elevating blood sugar levels, which was similar to that observed in adults. The incidence of side-effects was similar in both cases.

Contraindications for Baqsimi^™

Baqsimi^™ should not be taken in the following conditions:

Pheochromocytoma (rare adrenal gland tumor that secretes epinephrine and norepinephrine hormones)
Insulinoma (insulin-secreting pancreatic tumor derived from β-cells)
Hypersensitivity to glucagon
Allergy to any excipients in Baqsimi^™
Prolonged fasting
Chronic hypoglycemia
Adrenal insufficiency

Side Effects of Baqsimi^™

Some of the major side-effects include the following:

Headache
Nausea
Vomiting
Upper respiratory tract irritation
Nasal congestion / discomfort
Coughing
Sneezing
Epistaxis (bleeding from the nose)
Rhinorrhea (runny nose)
Redness of the eyes
Watery eyes
Itchy eyes/nose

Besides the common side-effects listed above, glucagon has also been known to cause anaphylactic shock (an extreme life-threatening allergic reaction) with breathing difficulties and hypotension (low blood pressure).

Conclusion

FDA approved drug Baqsimi^™can help treat severe hypoglycemia without an injection. The drug is delivered nasally and results in rapid elevation of blood sugar levels.

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