Renaissance Supports Launch of FDA-Approved Neffy® with Scalable Manufacturing

• Renaissance is manufacturing neffy®, the world’s first needle-free epinephrine nasal spray, now commercially available in the US.

• The six-year partnership between Renaissance and ARS Pharmaceutical led to the successful FDA approval and launch of neffy® in August 2024.

Renaissance Lakewood, LLC, a global contract development and manufacturing organization (CDMO), is manufacturing neffy®, the first and only needle-free epinephrine nasal spray. This product, which provides a treatment for severe allergic reactions, received approval from the U.S. Food and Drug Administration (FDA) on August 9, 2024, and is now commercially available in the US.

Neffy® represents a significant development in managing Type I allergic reactions, including anaphylaxis, by offering a needle-free alternative to traditional injectable treatments. This easy-to-use nasal spray aims to improve patient and caregiver experiences when managing allergic emergencies. Renaissance has supported ARS Pharmaceutical, Inc. (ARS) through all stages of neffy’s development, from research and clinical trials to full-scale manufacturing.

“Our partnership with ARS has been crucial for the successful development and launch of neffy,” said Kimberly Ernst, Vice President, Product Development and Laboratory Services at Renaissance. “We helped ARS optimize the formula and scale the manufacturing process from early stages to commercialization.”

Renaissance has also completed a campus expansion, adding two new packaging lines to meet the projected demand for neffy®, while ensuring the capacity to manufacture other nasal sprays. ARS’s President and CEO, Richard Lowenthal, expressed confidence in Renaissance’s ability to meet global market demands: “We appreciate Renaissance’s support and diligence in helping us make neffy available across the U.S.”