The FDA has approved the Unidose Liquid System (AptarGroup Inc) as the first and only nasal rescue treatment for acute repetitive seizures in patients with epilepsy.
The FDA has approved the Unidose Liquid System (AptarGroup Inc) as the first and only nasal rescue treatment for acute repetitive seizures in patients with epilepsy.1
The single-use, ready-to-use nasal delivery device can deliver a formulation in an emergency situation and is available to be administered by a non-healthcare professional to a patient during or after a seizure. The patient or caregiver is instructed to press a small plunger on the bottom of the device to release the drug in a single spray into the nostril, where the drug can be absorbed via the nasal mucosa.1
Noble International, recently acquired by Aptar and a part of Aptar Pharma’s services offering, recently developed a trainer device in partnership with patients to be used as part of a patient onboarding program for this new device.1
According to the website, Unidose Liquid System is applicable for therapies where a small and very precise amount of active drug formulation is required in a single nasal shot.2
“The launch of our Unidose System on the first and only U.S. FDA approved nasal rescue treatment for seizure activity once again demonstrates Aptar Pharma’s ability to help our customers develop and launch complex treatments,” stated Gael Touya, president of Aptar Pharma, in a prepared statement. “When we combine our nasal systems’ capabilities with Noble’s training devices for onboarding, we bring added value to our customers and further convenience for patients and consumers worldwide.”
1. Aptar’s nasal unidose device approved by US FDA for first nasal rescue treatment for frequent seizure activity [news release]. Crystal Lake, Ill.; BusinessWire: December 9, 2019. https://www.businesswire.com/news/home/20191209005155/en/Aptar%E2%80%99s-Nasal-Unidose-Device-Approved-U.S.-FDA. Accessed December 9, 2019.
2. Single Shot Nasal Unidose Systems with Proven Performance. Aptar Pharma website.https://pharma.aptar.com/en-us/dispensing-solutions/uds.html. Accessed December 9, 2019.