FDA OK's Nasal Powder Remedy for Severe Hypoglycemia

Studies find the new product works in under 15 minutes.

Eli Lilly's Baqsimi The FDA approves the first nasal glucagon treatment for severe hypoglycemia. Look for it in drug stores soon.

In late July, the FDA approved the first nasal glucagon powder for the emergency treatment of severe low blood sugar or hypoglycemia. Eli Lilly, the drug's maker, expects it in pharmacies by August.1

Glucagon is one of the first-line treatments for severe hypoglycemia, but is not stable in an aqueous form, the FDA says. Kits already on the market with powdered glucagon have to be reconstituted before the drug can be given to a patient, and that takes several steps. A caregiver may also have to figure out the correct dose for a child, based on body weight.1

The new nasal glucagon, called Baqsimi, delivers the glucagon as a dry power spray. It is in a portable, single-use, ready-to-use device. It's absorbed in the nose, so no inhalation is needed. It does not need refrigeration and can be kept at temperatures up to 86 degrees Fahrenheit. Children as young as 4 years have used it in studies.1,2

What the FDA Says

This new administration method may simplify the process of getting people help at a critical time, says Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, in a press release. Simplifying the process can be critical, Dr. Woodcock says, ''especially since the patient may have lost consciousness or may be having a seizure."1

More on Severe Hypoglycemia

Severe low blood sugar is defined as low blood sugar that is not treated and you then need someone to help you recover, the American Diabetes Association says. This is a severe event. If left untreated, low blood sugar can lead to loss of consciousness, seizures, coma and death.3

Among the symptoms: feeling shaky, nervous or anxious, along with feeling sleepy and weak. Vision may get blurry and the lips, tongue or cheeks could tingle or be numb.3

More on Baqsimi

The nasal glucagon boosts blood glucose levels by stimulating the liver to release stores of glucose into the blood stream.2
The FDA based its approval after looking at studies of both adults and child patients.Two studies of 83 and 70 adults with diabetes compared a single dose of the nasal glucagon to a single dose of glucagon injection in causing a blood sugar response to low blood sugar that was insulin induced. The new product increased blood sugar levels adequately, the FDA say. A study of the product given to 48 children produced similar results.1

Among people who can't use the new product are those with a rare tumor of the adrenal gland tissue (pheochromocytoma) or with a pancreatic tumor (insulinoma). Those known to be hypersensitive to glucagon should not take it.

If someone has been fasting for a long time, or if they have chronic low blood sugar or if they have adrenal insufficiency, they also should not use it, the FDA says. This is because they have low levels of glucose in the liver that could be released.1,2

As with any drug, adverse effects can occur. For Baqsimi, these include vomiting, headache, upper respiratory track irritation, watery eyes or red eyes along with itchy eyes. These side effects are similar to those experienced with injected glucagon, except the nasal delivery adds the possibility of nasal congestion and watery eyes.1,2

Eli Lilly Input

According to Lilly, the price of the new product is $280 for a one-pack and $561 for a 2-pack. But, if insurance covers, it can be as low as $25 for a two-pack or two one-packs.

With the approval so recent, however, ''we don't have a number yet regarding insurance coverage," says DeShong Perry-Smitherman, a spokesperson for Eli Lilly. There is also a Lilly Diabetes Solution Center to help patients with the costs, she say. It can be reached by phone, 833-808-1234.

The product is not meant to be self-administered, the Lilly spokesperson says. And it is not yet known if schools will stock it. "At this point Baqimi will only be available with a prescription once it is available in pharmacies in about three weeks," Perry-Smitherman says. That target date is mid-August.

Right now the shelf life is 18 months, but Lilly is hoping to extend that.

In adult patients, the mean time to treatment success was 11.6 minutes, according to Lilly, and the mean time across three pediatric age groups was 10.8 to 14.2 minutes.

Perspective from an ER Doctor

Robert Glatter, MD, is an emergency physician at Lenox Hill Hospital in New York. He reviewed the information on the new product for OnTrackDiabetes. "The drug may certainly have value in the more rapid treatment of hypoglycemia compared to IM glucagon [administered intramuscularly], especially in the setting of ongoing seizures, difficult IV [intravenous] access, or before an adequate IV can be established," Dr. Glatter says.

When glucagon is given intramuscularly, he says, it works to stimulate the liver to break down glycogen to glucose. "This process is not immediate and could take up to 10-15 minutes before glucose levels are restored to normal. Intranasal delivery is much quicker—taking effect in a few minutes—compared with the more prolonged IM route."

"The definitive treatment of hypoglycemia is with dextrose (glucose). In persons who are profoundly altered, comatose or seizing—and therefore unable to tolerate oral glucose—we place an IV and administer dextrose (glucose).  Since this process may take some additional time, the advent of intranasal application of gIucagon as a bridge before IV administration of glucose can be potentially lifesaving."

Another option, he say, is to place a special needle into the bone to infuse it if intravenous access is not possible. "While this requires some additional time and set up, intranasal application is still more expedient," he says.

He points out, too, that "intramuscular administration of glucagon can be cumbersome, requiring reconstitution of the powder with liquid prior to injection. Because of time constraints, a simple intranasal application can save precious minutes.''

Like other experts, he say that prolonged low blood sugar is dangerous. If it continues, he says, it "can have detrimental neurological effects on the brain as well as the heart, so anything we can do to speed up delivery of drug to treat hypoglycemia is certainly welcome.''

In addition to being used in hospital ERs, he says, ''the drug may also be useful to EMS providers, especially to those with difficult IV access, or those who may be unconscious or having a seizure. It’s akin to nasal delivery of Narcan, vital to treat opiate overdoses."

Dr. Glatter has no disclosures.

Updated on: September 4, 2019
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