Nasal Glucagon Baqsimi – A Radical Improvement for Severe Hypoglycemia

Lilly’s Baqsimi is a needle-free, simple treatment for severe hypoglycemia – bringing long-needed innovation to use of glucagon in emergency settings. 

New Easy-To-Use Glucagon Products Are Coming

Researchers have taken strides toward a future where glucagon delivery isn’t a multistep process. They are developing glucagon products that require no mixing—or injection. Their goal? A fast hypoglycemia treatment that lessens a caregiver’s stress during a tense emergency situation—and saves lives.

Testing, Testing

The race is on to bring easier-to-use devices to market. “Until there is a cure for diabetes, and that cure is readily available to everyone in the world who has to take insulin or [sulfonylureas], we need better ways to help people manage hypoglycemia,” says Elizabeth Seaquist, MD, an endocrinologist and professor of medicine in the Department of Medicine at the University of Minnesota. In the works:

Patch

Zosano Pharma is working on a patch with a microneedle underbelly. When the needles penetrate the skin, the coating of glucagon powder will enter the bloodstream and go to work.

Benefits: Caregivers may be less nervous about applying a patch than preparing and injecting a solution. It’s a quick and simple (it can be applied to any area of skin), single-step process. Plus, it’s easy to carry on you at all times.

Drawbacks: In theory, the microneedle administration would be slower at getting glucagon into the system than the current intramuscular injection because there is more blood flow in muscles than just under the skin. “But we don’t know how much a difference that makes until comparison studies are done,” Klonoff says.

Another drawback is that the patch will need an adhesive to stick to the skin, which could cause a rash or other reaction. “Though that’s a minor problem compared to severe hypoglycemia,” Seaquist says.

Availability: Zosano Pharma completed Phase 2 clinical trials in 2015 but put further trials on hold in March 2016 to focus its resources on a product unrelated to diabetes. It’s unclear when patch trials will resume.

Pen

If all goes as planned, Xeris Pharmaceuticals’ device will work similar to EpiPens and other pens prefilled with medicines, such as insulin and type 2 injectable drugs. The device will contain a stable form of glucagon that’s already dissolved into liquid, says Rickels.

Benefits: Because the glucagon is premixed, the caregiver simply removes the cap and injects it into the person with severe hypoglycemia. The pen would likely push glucagon into the system as quickly as the current syringe kit, says Klonoff.

Drawbacks: Creating potent yet stable premixed glucagon is a challenge. Klonoff says researchers are testing ways to ensure the glucagon molecule is not altered or made less potent when dissolved and stored in liquid.

Availability: The pen is currently in Phase 2 clinical trials, and Phase 3 trials will follow. Xeris expects to submit a new drug application to the FDA in the first half of 2018. The anticipated approval date is a year later.