FDA approves Unidose device for new nasal seizure rescue treatment

23 Jan 2020

The single-use, ready-to-use, one-step nasal delivery device can deliver a formulation in an emergency situation quickly and easily.

Aptar Pharma's patented Unidose Liquid System is the device delivering a new nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged six and older suffering from acute repetitive seizures.

FDA approves Unidose device for new nasal seizure rescue treatment
Aptar’s Unidose Device.

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.

Proven 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. These proven platforms 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 via Aptar Pharma Services

This new 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 and derisk approval.

“The launch of our Unidose System for this new 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. “Our proven nasal systems combined with our lab and analytical service capabilities create substantial value for our customers and help them secure approval. The ultimate end result is that we help expand life-saving treatments with our patient-friendly systems.”

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