The US Food and Drug Administration (FDA) has approved Aptar Pharma's Bidose nasal spray device for a breakthrough therapy in the field of depression.
Aptar Pharma said the approval marks the first FDA nod and US launch of a prescription drug using its patented Bidose nasal spray delivery system.
The company noted that the approval demonstrates its expertise in developing patient-friendly drug delivery solutions for breakthrough medicines.
The company has designed its Bidose liquid system as a primeless, intuitive and easy-to-use device with 360° functionality for local or systemic delivery of drugs. The device is manufactured with precise spray characteristics to provide accurate two-shot nasal drug delivery.
Aptar Pharma’s advanced manufacturing facility in Congers, New York, offered laboratory and other organizational capabilities to support nasal and injectable drug delivery systems, where the customized Bidose liquid device is produced.
The company said that the US FDA approval for the advanced therapy is an example of a combination product, and benefited from a comprehensive portfolio of stage-specific packages designed to proactively address regulatory needs to accelerate approval.
Aptar Pharma president Gael Touya said: “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. 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.”
In October 2018, Aptar Pharma has introduced a new portable and ready-to-use drug delivery solution, dubbed PureHale, for respiratory care.
The PureHale device has been developed for use in combination with saline or other natural ingredient formulations to help relieve the symptoms of upper respiratory system conditions.
As a result of increasing pollution, need for upper respiratory relief has become important and PureHale, featuring bag-on-valve system, is an advanced technology that distributes a continuous fine mist between 20µm and 30µm, enabling to clean, moisturize and sooth the upper respiratory tract.
The device is designed to reduce irritations caused by coughs, colds, allergies, respiratory problems and dry nose/throat issues.