FDA approves nasal drug delivery device for breakthrough treatment of depression19 Mar 2019
Aptar Pharma’s Bidose liquid system is designed for local or systemic delivery of drugs.
Aptar Pharma's Bidose nasal spray device has been approved by the FDA for a breakthrough therapy in the field of depression. This marks the first FDA approval and US launch of a prescription drug using Aptar Pharma’s patented Bidose nasal spray delivery system.
This approval again demonstrates Aptar Pharma’s expertise in developing patient-friendly drug delivery solutions for breakthrough medicines.
Patented Bidose Technology Platform
Aptar Pharma’s Bidose liquid system is designed for local or systemic delivery of drugs. As a robust, primeless, intuitive and easy-to-use device with 360° functionality and precise spray characteristics, the Bidose system provides accurate two-shot nasal drug delivery.
The Aptar Pharma Bidose and Unidose systems offer biotech and pharmaceutical companies effective and reliable intra-nasal delivery platforms for a variety of medicines including potential life-saving treatments and treatments of severe conditions.
This nasal product platform can enhance brand image via an elegant and intuitive design while limiting the volume of drug accessible to patients. The devices can also integrate wireless connectivity technologies.
Accelerated Development Support via Aptar Pharma Services
This breakthrough therapy approval is an example of a Combination Product, and benefited from Aptar Pharma’s Services offering, a comprehensive portfolio of stage-specific packages designed to proactively address regulatory needs to accelerate approval.
Leveraging its extensive value-adding capabilities including lab and analytical services, proven regulatory expertise - with dedicated Regulatory Affairs experts and fast approval data packages - and customized drug delivery solutions, Aptar Pharma’s Services can enable an expedited approval and launch in the competitive pharmaceutical space.
“We are pleased that Aptar Pharma’s Bidose nasal delivery device has been approved by the FDA for this breakthrough therapy in the field of depression,” explained Gael Touya, President, Aptar Pharma. “This project marks close to a 10-year customer collaboration and once again demonstrates Aptar Pharma’s ability to develop and launch complex drug delivery systems worldwide.”
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