Dec 9, 2019   SOURCE: BusinessWire

Aptar’s Nasal Unidose Device Approved by U.S. FDA for First Nasal Rescue Treatment for Frequent Seizure Activity

AptarGroup, Inc. (NYSE: ATR), a global leader in drug delivery, consumer product dispensing and active packaging solutions, today announced that 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.

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Aptar's Unidose Device (Photo: Aptar)

Aptar's Unidose Device (Photo: Aptar)

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.”

About Aptar

Aptar Pharma and Noble International are part of AptarGroup, Inc. Aptar is a leading global supplier of a broad range of innovative dispensing, sealing and active packaging solutions for the beauty, personal care, home care, prescription drug, consumer health care, injectables, food and beverage markets. Aptar uses insights, design, engineering and science to create innovative packaging technologies that build brand value for its customers, and, in turn, make a meaningful difference in the lives, looks, health and homes of people around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 14,000 dedicated employees in 18 different countries. For more information, visit www.aptar.com/pharma.

This press release contains forward-looking statements. Words such as “future” and other similar expressions or future or conditional verbs such as “will” are intended to identify such forward-looking statements. Forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on our beliefs as well as assumptions made by and information currently available to us. Accordingly, our actual results may differ materially from those expressed or implied in such forward-looking statements due to known or unknown risks and uncertainties that exist in our operations and business environment including, but not limited to: the successful integration of acquisitions; the regulatory environment; and competition, including technological advances. For additional information on these and other risks and uncertainties, please see our filings with the Securities and Exchange Commission, including the discussion under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Form 10-Ks and Form 10-Qs. We undertake no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.