AGG's Due Diligence of FDA Regulations Aids ARS Pharmaceuticals in Improving Treatment for Severe Allergic Reactions


A Type I severe allergic reaction can be a potentially life-threatening event requiring immediate treatment with epinephrine, the only FDA-approved medication for these reactions. Although epinephrine autoinjectors are highly effective, certain limitations can delay treatment in an emergency, including fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. To address these issues, ARS Pharmaceuticals, Inc. (“ARS”), headquartered in San Diego, California, is developing neffy™, a needle-free intranasal epinephrine spray for use as a rescue medication for people with severe allergic reactions. neffy™ has a unique absorption technology that is easy to use and is designed to rapidly administer injection-like absorption of epinephrine in a nasal spray device for patients at risk of severe allergic reactions to food, medications, and insect bites that could lead to life-threatening anaphylaxis.


ARS was entering into a merger agreement with Silverback Therapeutics (Nasdaq: SBTX) (“Silverback”) to focus on the potential regulatory approval and commercialization of neffy™ and needed to conduct time-sensitive, FDA-related regulatory due diligence on Silverback’s assets and compliance. AGG Food & Drug attorneys Bob Durkin, Alan Minsk, and Laura Dona served as ARS’ FDA regulatory counsel to aid in its merger with Silverback. Bob, Alan, and Laura reviewed documents and assisted in drafting contractual language for ARS’ corporate counsel, which would help bring the company a step closer to improving treatment options for patients and caregivers when a serious allergic reaction occurs.


ARS and Silverback announced on July 21, 2022, that the companies had entered a definitive agreement, and the combined company will focus on the potential regulatory approval and commercialization of neffy™. Upon stockholder approval, the combined company is expected to operate under the name ARS Pharmaceuticals and trade on the Nasdaq under the ticker symbol “SPRY.”

“We are extremely pleased to announce this proposed merger with Silverback, which we believe enables ARS to maximize the paradigm-changing opportunity of neffy™,” said Richard Lowenthal, M.Sc., MSEL, co-founder and chief executive officer of ARS, in a press release regarding the merger. “neffy™ is on the cusp of achieving what has not been possible before – the ability to deliver epinephrine with comparable pharmacokinetics to an intramuscular injection, but with a simple to administer nasal spray.”

To read the full press release, please click here.