Aptar Pharma, a leading provider of drug delivery devices worldwide today announced that its patented Unidose Liquid System is the device which delivers Tosymra™ (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.
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.”
See full Press Release for details.