FDA for the emergency treatment of patients with allergic reactions (Type I), including anaphylaxis. This marks the first regulatory approval worldwide for nasally-delivered epinephrine.
Aptar’s Unidose is a single-use, ready-to-use, one-step nasal delivery system used to administer neffy to a patient during a severe allergic reaction. During such an event, the patient, healthcare professional, caregiver or user presses a small plunger on the bottom of the nasal spray system to release the drug in a single spray into the nostril.
Stephan B. Tanda, Aptar President and CEO, stated, “Aptar has been a leader in nasal delivery of medication for more than 30 years. We are proud of our role in the pharma industry to increase the use of nasally delivered medications that help promote adherence and ease of use for patients.”
Unidose (UDS) and Bidose (BDS) Technology Platforms:
Aptar’s UDS and BDS technology platforms are designed to be robust, reliable and intuitive systems for easy administration by patients or caretakers. These drug delivery systems are designed and manufactured with strict quality controls intended to meet FDA’s guidelines for reliability. They offer biotech and pharmaceutical companies effective and reliable single or two-shot intranasal delivery for a variety of medicines including for emergency use and treatments of severe conditions. They can also be integrated with wireless connectivity technologies.
Accelerated Development Support via Aptar Pharma Services:
This novel treatment for severe allergic reaction 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 help accelerate approval.
“The approval of neffy, which uses our Unidose System, and is the first nasally-delivered epinephrine treatment for severe allergic reaction, including anaphylaxis, once again demonstrates Aptar Pharma’s ‘formulation to patient’ focus on helping our customers develop complex, innovative treatments,” stated Gael Touya, President, Aptar Pharma. “When we combine our nasal systems’ capabilities with our Aptar Pharma Services offering, we bring added value to our customers, and aim to provide further convenience for patients and their caregivers worldwide.”
About Aptar:
Aptar Pharma is part of AptarGroup, Inc., a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, beverage, personal care and home care. Using market expertise, proprietary design, engineering and science to create innovative solutions for many of the world’s leading brands, Aptar in turn makes a meaningful difference in the lives, looks, health and homes of millions of patients and consumers around the world. Aptar is headquartered in Crystal Lake, Illinois and has over 13,000 dedicated employees in 20 countries. For more information, visit www.aptar.com.
About ARS Pharmaceuticals:
ARS is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis. The company is commercializing neffy®, an epinephrine nasal spray product for patients with Type I allergic reactions, including food, medications and insect bites that could lead to life-threatening anaphylaxis.
For more information, visit www.ars-pharma.com.
