FDA Approves First Nasal Rescue Treatment for Frequent Seizure Activity

AptarGroup Inc. a firm focused on drug delivery, consumer product dispensing, and active packaging solutions, announced its patented Unidose Liquid System is the device delivering the first and only nasal rescue treatment approved by the U.S. FDA, which has recently launched in the U.S. to treat acute repetitive seizures in people living with epilepsy. This ready-to-use rescue treatment can be used when and where a seizure cluster occurs thanks to Aptar’s proven, intuitive and convenient Unidose Liquid System.
 
Noble International, recently acquired by Aptar and part of Aptar Pharma’s services offering, developed a trainer device in partnership with the customer to be used as part of a patient onboarding program for this new drug product.
 
Stephan Tanda, Aptar president and CEO, stated, “This approval and successful market launch further demonstrate the broad potential for Aptar’s patient-friendly drug delivery solutions and service offerings which help our pharmaceutical customers address unmet healthcare needs. We are pleased to offer a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.”
 
Solution for Nasally Administered Treatments
Aptar’s Unidose Liquid System is a single-use, ready-to-use one-step nasal delivery device which can deliver a formulation in an emergency situation quickly and easily and can be administered by a non-healthcare professional to a patient during or after a seizure. 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 spray into the nostril, where the drug can be quickly absorbed via the nasal mucosa.
 
Patented Unidose and Bidose Technology Platforms
Aptar’s Unidose and Bidose platforms are robust, primeless, and intuitive 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.
 
Accelerated Development Support and Training via Aptar Pharma Services
This innovative rescue treatment for seizure activity 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.
 
“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, Aptar Pharma. “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.”