Aptar’s Nasal Unidose Device Approved by US FDA for First Needle-Free Rescue Treatment for Severe Hypoglycemia

Aptar Pharma, a provider of dispensing and drug delivery systems, announced that its Unidose Powder System was approved by the U.S. Food and Drug Administration (FDA) for an intranasal, needle-free rescue treatment drug intended to treat severe hypoglycemia in people with diabetes.

Aptar’s Unidose Powder System is a single-use, ready-to-use, one-step nasal delivery device which can deliver a powder formulation in an emergency situation. During such an event, the patient or caregiver presses a small plunger on the bottom of the device to release the drug in a single powder puff into the nose, the drug is designed to be absorbed via the nasal mucosa. The Unidose Powder System is meant to be a simple alternative to injectable kits avoiding time-consuming assembly.

Aptar’s Unidose and Bidose platforms are designed to have 360° functionality and precise nasal drug delivery for a variety of medicines including potential life-saving drugs and treatments of severe conditions. The devices are also made to integrate wireless connectivity technologies.

The container which protects and stores the Unidose Powder System was developed by Aptar CSP Technologies, the material science unit of Aptar. This container incorporates Aptar’s three phase ActivPolymer technology which is meant to ensure extended moisture protection for the shelf-life of the drug, mitigating the impact of changing environmental conditions associated with temperature, and relative humidity.

This therapy, in the field of diabetes, is an example of a Combination Product submission and a portfolio of stage-specific development packages. Aptar’s Regulatory Affairs experts and analytical scientists help customers address regulatory needs to accelerate approval.

“We are pleased to announce that Aptar Pharma’s Unidose Powder System has been approved by the FDA for the first intranasally-delivered, needle-free rescue treatment for severe hypoglycemia that provides a more patient-friendly delivery approach. Our active packaging container helps to protect the device and better ensure its quality until the moment of use,” says Gael Touya, President, Aptar Pharma.