September 30, 2024 –Renaissance Lakewood, LLC (“Renaissance”), a leading global contract development and manufacturing organization (“CDMO”) is proud to be manufacturing neffy®, which is now commercially available in the US.
On August 9, 2024, the U.S. Food and Drug Administration (“FDA”) approved ARS Pharmaceutical, Inc.’s (“ARS”) new drug application for neffy 2mg (epinephrine nasal spray), the world’s first and only needle-free, intranasal spray treatment for Type I allergic reactions, including anaphylaxis in adults and children who weigh ≥30 kg (66 lbs.).
neffy is the first and only needle-free treatment option for patients and caregivers living with severe (Type 1) allergic reactions. neffy is an easy-to-carry and easy-to-use epinephrine medication alternative to needle-based treatments. Type I allergic reactions are often caused by triggers such as allergies to certain foods, medications, or insect bites that can lead to potentially life-threatening anaphylaxis. neffy marks the first regulatory approval worldwide for epinephrine delivered as an intra-nasal spray.
The six-year partnership between Renaissance and ARS has involved every stage of development, from initial research and clinical trials to full-scale manufacturing and commercialization. By combining our manufacturing capabilities with the expertise of ARS, we have addressed the unmet medical need for alternative treatments for patients experiencing Type I allergic reactions, including anaphylaxis.
The intra-nasal spray is designed for needle-free and rapid administration, allowing patients or caregivers to quickly deliver the medication at the first signs of an allergic reaction. Prompt administration of epinephrine is key to managing anaphylaxis.
Kimberly Ernst, Vice President, Product Development and Laboratory Services at Renaissance said: “Our partnership with ARS has been crucial for the successful development and launch of neffy. We have helped ARS optimize the neffy formula and design a scalable manufacturing process, from early clinical stages to final registration and now to the first commercial batches.
This program has included developing and validating analytical, spray and microbiological methods. In addition, the manufacturing process development employed quality-by-design principles to ensure robust and repeatable results.”
Eric Kaneps, Vice President of Sales and Marketing added, “Renaissance offers unmatched pre-commercialization support from development services to large-scale commercial manufacturing. Our proven track record makes us the CDMO partner of choice for any nasal program.”
To ensure the capacity to quickly respond to growing global market demands, Renaissance recently completed a campus expansion and also invested in two additional packaging lines, which will support the forecasted volumes for this important product while assuring ample capacity for other nasal sprays manufactured at Renaissance.
Richard Lowenthal, Co-Founder, President, and CEO of ARS, added: “We appreciate the excellent support provided by Renaissance throughout the development of neffy and their diligence in meeting our launch timing for the U.S. market. We were thrilled to make neffy available to patients across the country last week and have great confidence in Renaissance to reliably supply neffy worldwide.”
About Renaissance Lakewood, LLC (“Renaissance”)
Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech. With over 20 years of experience in nasal sprays and sterile dosage forms, Renaissance has a consistent track record of providing exceptional service and resources to clients from the development stage through commercial launch. Learn more about Renaissance at: www.renpharm.com.
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