Aptar Pharma’s Nasal Unidose Device Approved for TosymraTM Sumatriptan Spray

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Aptar Pharma, a leading provider of drug delivery devices worldwide and part of AptarGroup, Inc. announced that its patented Unidose Liquid System is the device which delivers TosymraTM (sumatriptan) Nasal Spray 10mg, for the acute treatment of migraine in adults.

Now available in the U.S., Tosymra was approved by the U.S.Food and Drug Administration (FDA) in January, 2019 and is being commercialized by Upsher-Smith Laboratories, LLC.

For migraine sufferers, there is a continued need for reliable and efficacious treatment options. Tosymra nasal spray is formulated using a proprietary excipient to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection. Aptar’s Unidose device delivers one dose of Tosymra as a single spray providing a convenient, patient-friendly delivery approach.

This approval and launch again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for medicines. Aptar offers 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 System is a single-use, ready-to-use one-step nasal delivery device which can deliver a liquid or powder formulation quickly, easily and reliably. Patients simply press a small plunger on the bottom of the device to release the drug in a single shot into the nose, 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 easy-to-use 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

Drug Development Support via Aptar Pharma Services
This migraine treatment 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 obtain approval.

“We are pleased that Aptar Pharma’s Unidose System has once again been approved by the FDA and launched with an important new nasal treatment for acute treatment of migraine that provides a patient-friendly delivery approach,” commented Gael Touya, President, Aptar Pharma. “Our lab and analytic service capabilities combined with our unique drug delivery devices create tremendous value for our customers and help them secure approval. The ultimate end result is that we help expand access to treatments with our life-improving, patient-friendly systems, something for which we are very proud.”

About Aptar Pharma
Aptar Pharma is part of AptarGroup, Inc., 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.

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