Aptar Pharma’s Nasal Unidose Device Approved by US FDA
Aptar Pharma recently announced that its patented Unidose Liquid System is the device delivering a new nasal spray approved by the US FDA as a rescue treatment for people with epilepsy aged 6 and older suffering from acute repetitive seizures. 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.
This approval again demonstrates Aptar’s expertise in developing patient-friendly drug delivery solutions to help pharmaceutical customers address unmet healthcare needs. Aptar offers a broad portfolio of innovative technologies and wide array of services to meet the highest quality standards of the pharmaceutical industry.
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.
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.
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 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. “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.”
Aptar Pharma is part of AptarGroup Inc., a global leader in the design and manufacturing of a broad range of drug delivery, consumer product dispensing and active packaging solutions. Aptar uses insights, design, engineering and science to create dosing, dispensing and protective packaging technologies for the world’s leading brands, in turn making a meaningful difference in the lives, looks, health and homes of millions of people around the world. Aptar’s innovative solutions serve a variety of end markets including pharmaceutical, beauty, personal care, home, food and beverage. The company is headquartered in Crystal Lake, IL, and has 14,000 dedicated employees in 17 countries. For more information, visit www.aptar.com.
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