Expanding Diabetes Medication Options Meets More Patient Needs

FDA approvals lead to the introduction of new formulations of glucagon, insulin, and statin therapy for patients with diabetes and cardiovascular disease, fulfilling a precept of precision medicine.

with Julie Settles, MSN, APRN

First Non-Injection Glucagon Gains FDA Approval

After a 4-month delay, the first Intranasal delivery method for glucagon was approved by the Food and Drug Administration (FDA) to manage severe hypoglycemia.1 This powder formulation will be available in single-use dispensers for individuals who require insulin to manage their diabetes so long as they are at least four years of age

Glucagon for severe hypoglycemia now comes in a intranasal powdered form.

The branded product—Baqsimi (Eli Lilly and Company)—allows for needle-free administration of glucagon in individuals who require emergency treatment for a severe hypoglycemic episode.2

According to a survey of individuals (n = 102) with diabetes requiring insulin management,3 83% responded that they had been given instructions on the use of a glucogon emergency kit. While just 60% of the patients had one, only 19% of these patients had used their kit to manage a bout of severe hypoglycemia.

A majority of those surveyed indicated a preference for a nasal delivery over an injection, and indicated a belief that anyone else having to deal with a hypoglycemic episode would be more comfortable administering a nasal spray than giving an injection. While this study is dated, the findings offer a fair argument for providing an alternative route of administration for glucagon.3

Approval was granted following review of the results from three phase 3 studies evaluating the safety (n=83) and efficacy (n=70) of single dose, nasally-administered glucagon in response to hypoglycemic episodes.3-5

Clinical results presented for product review included two phase 3, randomized, multicenter, open-label cross-over studies comparing nasal administration of Baqsimi (3 mg) to a glucagon injection (1 mg), and an ongoing, open-label usability trial in children and their caregivers,3-5 Julie Settles, MSN, APRN, medical launch lead at Lilly USA, in Greenwood, Indiana, told EndocrineWeb.

Clinical data from three phase 3 studies were as follows:

  • study 1 involved 70 adults with type 1 diabetes3
  • study 2 included 83 adults with either type 1 or type 2 diabetes4
  • study 3 enrolled 26 children ages 4 to 17 years with type 1 diabetes5

The results among adults demonstrated noninferiority (100% and 98.8%, respectively) by raising blood glucose to ≥ 70 mg/dL or achieving a ≥ 20 mg/dL rise in plasma glucose from baseline levels within 30 minutes of glucagon administration following an episode of insulin-induced hypoglycemia.3,4

In a randomized, single-center, crossover, user-experience study with children,5 rates of successful administration, administration time, and preference for the glucagon delivery device against injectable glucagon were evaluated in real life scenarios of severe hypoglycemia.

Individuals both trained and not trained were able to administer the intranasal glucagon over an injection (90% trained and 91% untrained were successful) vs. injectable (16% trained and 0% untrained) with a median 30 seconds as compared to 73 seconds for successful dosing.5 The intranasal devise was more preferred and gave the users a greater feeling of comfort in delivery.

The side effect profile of intransal glucagon is similar to that of the injectable form minus any needle site skin irritation but with the addition of nasal congestion and watery eyes, as might be expected given the mode of delivery.6

A package warning will be included for patients who have adrenal insufficiency, chronic hypoglycemia, or have been fasting for an extended time period, and is contraindicated in people with a known sensitivity to glucagon, as well as patients who have pheochromocytoma or insulinoma tumors of the pancreas.

“This new way to administer glucagon may simplify the process, which can be critical during an episode,” said Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA.1

The list price for a Baqsimi in the United States is expected to be $280.80/pack and $561.60 for a two-pack, according to a corporate statement, adding that Baqsimi is expected to be available in pharmacies at this end of this month.1

First FDA-Approved Powder Form of a Statin Available

Sun Pharmaceutical Industries announced the launch of Ezallor Sprinkle—an extended-release-coated capsule containing rosuvastatin intended for adults for whom swallowing pills is a problem and is the first lipid-lowering agent to offer a flexible delivery option to meet the needs of an aging population with hyperlipidemia.7

This HMG Co-A reductase inhibitor is a novel, powered form of rosuvastatin delivered as extended-release-coated pellets and approved for use in adults (at least 18 years of age) that may be added to soft food such as applesauce, administered by nasogastric tube, or swallowed to facilitate long-term, once-daily administration.

Making a statin available in a form that doesn’t require swallowing a pill fits a growing need given the ever greater number of aging individuals with cardiovascular disease; in fact, an estimated one in four adults have dysphasia and might benefit by having the option of this product.8

Certainly,  patients under treatment for cancer (ie, radiation, surgery, chemotherapy) and at least one in three individuals in long-term care facilities are good candidates for this formulation.8,9

Ezallor Sprinkle is indicated as an adjunct to diet for the treatment of:10

  • Hypertriglyceridemia
  • Primary lipoproteinemia (type III hyperlipoproteinemia)
  • Other lipid-lowering treatments (eg, LDL apheresis)
  • In addition, Ezallor Sprinkle capsule may be used as monotherapy if preferred treatments are unavailable to reduce low density lipoprotein-cholesterol (LDL-C), total cholesterol, and ApoB cholesterol in patients with homozygous familial hypercholesterolemia.
  • This formulation of rosuvastatin was not studied in Fredrickson type I and V dyslipidemias.

Ezallor Sprinkle may be delivered by mixing into soft food such as applesauce and administered through a nasogastric tube as well as swallowed, to best achieve once-daily dosing in compromised individuals.10 The product can be taken at any time of day, on an empty stomach or with food.

“The risk of medication errors increases when people have difficulty swallowing due to crushing of medicines that shouldn’t be crushed, or from residual medication left over in crushing devices,” according to Christopher M. Chappel, MD, medical director of Chappel Senior Care and principal investigator of the Chappel Group Research in Kissimmee, Florida. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.”7

This non-swallow statin formulation is available in four dosages: 5 mg, 10 mg, 20 mg, and 40 mg; however, the highest dose is intended only for patients not reaching their LDL-C goal at the 20 mg dose.10

Ezallor Sprinkle is contraindicated in patients with any known sensitivity to rosuvastatin as as well as anyone with active liver disease, and women who are pregnant or breastfeeding.10 In the controlled clinical trials database, the most common adverse reactions with rosuvastatin were headache, myalgia, abdominal pain, asthenia, and nausea.

FDA Gives Nod tp Ready-to-Use IV Insulin

The FDA approved the first insulin available as an intravenous solution—Myxredlin—Insulin Human in 0.9% Sodium Chloride, to meet the growing need in hospitalized patients,11 according to Water Street Healthcare Partners, an investment group in partnership with Celerity Pharmaceuticals.

This IV administered insulin allows for an extended shelf life of 30 days when stored unopened (to avoid light exposure) at room temperature (77 degrees Fo) or 24 months under refrigeration (36 – 46 degrees Fo). The product is packaged in a standardized concentration of 100 units/100 mL in a flexible plastic container.12

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