Unidose device approved for Tosymra sumatriptan spray3 Oct 2019
Provides migraine sufferers with a convenient, patient-friendly delivery approach.
Aptar Pharma's patented Unidose Liquid System has been approved as the device that delivers Tosymra (sumatriptan) Nasal Spray 10 mg, for the acute treatment of migraine in adults.
Now available in the US, Tosymra was approved by the US FDA in January 2019 and is being commercialized by Upsher-Smith Laboratories.
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.
Aptar’s Unidose System is a single-use, ready-to-use one-step nasal delivery device that 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.
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.
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.”
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