A ready-to-use nasal drug delivery device for powder formulations is being used for Eli Lilly’s Baqsimi, which the drug maker calls the first and only nasally administered glucagon. FDA just approved the one-step, needle-free treatment for severe hypoglycemia in people with diabetes ages four years and above, the company reported.
Aptar’s Unidose Powder System was selected for the emergency-use product for severe hypoglycemia rescue. No reconstitution is needed. "Severe hypoglycemia is an unpredictable event for people with diabetes that can happen anytime, anywhere. It's an experience that can be very stressful and difficult for those helping a person in a low blood sugar emergency," explained Dr. Sherry Martin, Vice President of Lilly Medical Affairs, in a press release. "The FDA's approval of BAQSIMI may help people prepare for these moments with an innovative product that has the simplicity of nasal administration."
To deliver Baqsimi, patients or caregivers only need to press a small plunger on the bottom of the Unidose Powder System to release a single powder puff of the drug into the nose. The system provides an alternative to injectable kits that may require reconstitution or assembly, Aptar reported in a news release.
Aptar reported that Baqsimi is the first FDA approval of a prescription drug in the Unidose Powder System and Aptar’s first combination of a drug delivery device with a protective active packaging container. It is also the first approval and customer launch combining the technologies of Aptar Pharma and Aptar CSP Technologies, which developed the container that protects and stores the Unidose Powder System. It employs Aptar’s Activ-Polymer technology for ensuring moisture protection throughout shelf life.
“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,” stated Gael Touya, president, Aptar Pharma, in a news release. “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.”