In an unexpected twist, federal regulators have rejected the authorization of a pioneering nasal spray intended for the treatment of severe allergic reactions. The decision was delivered late Tuesday, citing a need for additional research on this potential groundbreaking replacement to traditional injection methods like the EpiPen.
The U.S. Food and Drug Administration (FDA) communicated to ARS Pharmaceuticals, a San Diego-based company, the mandate for more comprehensive studies. The testing would focus on the repeated use of epinephrine, a life-saving drug used to counter potentially fatal anaphylactic reactions. The proposed study demands a comparative examination between the administration of the said drug through the company’s revolutionary nasal spray device and conventional injections.
The FDA’s decision arrived just four months after its Advisory Committee had advocated for the approval of the device, named Neffy. However, the FDA retains the prerogative to deviate from the committee’s suggestions, which in this case, it opted to do so.
Despite the setback, Richard Lowenthal, CEO and President of ARS, remains undeterred. He voiced his company’s intention to challenge the FDA’s decision and plans to resubmit an application in early 2024.
ARS’s novel product is amongst an array of needle-free devices in development, designed to manage perilous reactions to food, insect stings, and medications. If successful, the device could transform the lives of the 33 to 45 million Americans living with severe allergies to various triggers.
However, the FDA’s call for further trials has incited discontent among advocates for people with allergies, expressing frustration at the delay. Sung Poblete, CEO of the nonprofit organization, Food Allergy Research & Education, expressed disappointment on behalf of the community. “Our community was hopeful that this innovative solution would soon be available to over 10% of Americans living with life-threatening food allergies. Instead, we are confronted with a prolonged wait imposed by the FDA,” Poblete articulated in a statement.
