FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia

25 Jul 2019

Aptar’s nasal Unidose device - the result of a 10-year customer collaboration - marks the first FDA approval of a prescription drug using the company’s patented Unidose Powder System.

AptarGroup's Unidose Powder System has been approved by the FDA for an intranasal, needle-free rescue treatment drug intended to treat severe hypoglycemia in people with diabetes.

FDA approves Aptar's needle-free rescue treatment for severe hypoglycemia
Aptar’s patented Unidose Powder System. (Photo: courtesy of Aptar.)

This marks the first FDA approval of a prescription drug using Aptar’s patented Unidose Powder System and is Aptar’s first combination of a drug delivery device with a protective active packaging container.

Solution for nasally administered powder treatments

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 quickly and easily. 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, where the drug can be quickly absorbed via the nasal mucosa. Aptar’s Unidose Powder System is an alternative to injectable kits that may require assembly, including a multistep, time-consuming process of mixing powder and liquid.

Patented Unidose and Bidose technology platforms

Aptar’s Unidose and Bidose platforms are robust, primeless, and easy-to-use systems with 360° functionality and precise nasal drug delivery. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including potential life-saving drugs and treatments of severe conditions. The devices can also integrate wireless connectivity technologies.

Integrated active packaging container

This is the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies. The novel container, which protects and stores the Unidose Powder System, was developed by Aptar CSP Technologies, the global material science unit of Aptar, providing innovative, highly engineered advanced active packaging solutions that protect sensitive drug products. The container incorporates Aptar’s three-phase Activ-Polymer technology which ensures extended moisture protection for the shelf-life of the drug, mitigating the impact of changing environmental conditions associated with temperature and relative humidity.

Accelerated development support

This innovative therapy in the field of diabetes is an example of a Combination Product submission and benefited from Aptar Pharma’s Services offering a comprehensive portfolio of stage-specific development packages. Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively 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,” commented Gael Touya, President, Aptar Pharma. “This project marks a nearly 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments with patient-friendly delivery systems worldwide.”

Stephan Tanda, Aptar’s President and CEO added: “This successful approval confirms the value that we are bringing to our customers in the highly competitive pharmaceutical and biotech industries. With decades of experience in the long-term testing and development phases that are required by regulatory agencies, we are building a stronger solutions platform for the future, and this launch is a glimpse of that future. Our lab and analytic service capabilities combined with our unique drug delivery devices and active packaging solutions create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to life-saving treatments with our patient-friendly systems.”

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