AptarGroup, a specialist in dispensing and drug delivery solutions, has announced the Food and Drug Administration (FDA) approval of its unidose powder system to treat severe hypoglycemia in people with diabetes.
The device will provide a needle-free rescue treatment drug for this indication, and is the first approval by the FDA of a prescription drug using Aptar’s patented unidose powder system.
Aptar’s unidose powder system is a single-use, ready-to-use, one-step nasal delivery device which aims to deliver a powder formulation quickly and easily in emergency situations. In order to activate the device, the patient or caregiver needs to press a small plunger on the bottom of the device in order to release the drug in a single powder puff into the nose. Here, the drug can be quickly absorbed via the nasal mucosa. The system provides an alternative to injectable kits that may require assembly, multiple steps, and the process of mixing powder and liquid. The device is also able to integrate with wireless technologies.
This is the first FDA approval and customer launch which combines the technologies of Aptar Pharma and Aptar CSP Technologies. The novel container which protects and stores the unidose powder system was developed by the global material science unit of Aptar - Aptar CSP Technologies. The container aims to incorporate Aptar’s three phase Activ-Polymer Technology to ensure extended moisture protection for the shelf-life of the drug. As a result, this mitigates the impact changing environmental conditions associated with temperature and relative humidity can have on the drug.
Gael Touya, president, Aptar Pharma commented: “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.
“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.”