FDA Greenlights Groundbreaking Nasal Spray for Life-Threatening Allergies

Anaphylaxis drives over 30,000 people to emergency rooms annually in the U.S., resulting in more than 2,000 hospitalizations and over 230 deaths.

WASHINGTON — The FDA has approved the first needle-free nasal spray to combat severe allergic reactions—a significant breakthrough in allergy treatment.

The approved spray, developed by ARS Pharmaceuticals Inc., offers a new emergency treatment for adults and older children experiencing life-threatening allergic reactions, known as anaphylaxis.

Anaphylaxis is a severe immune response triggered by foods, insect stings, or medications, presenting symptoms like hives, swelling, itching, vomiting, and difficulty breathing.

Marketed as Neffy, this device could revolutionize treatment for the estimated 33 to 45 million Americans with severe allergies to various triggers. It addresses a dire medical need, especially given the misuse and underutilization of existing auto-injectors like EpiPens.

Dr. Thomas Casale, an allergist at the University of South Florida, highlighted that 40% of the 6 million annual auto-injector prescriptions go unfilled. Even when filled, improper usage is common.

Neffy is intended for individuals weighing at least 66 pounds. Administered as a single dose in one nostril, a second dose can be given if symptoms don’t improve.

Dr. Kelly Cleary, a pediatrician, and director at the Food Allergy Research & Education, emphasized that the new spray could be transformative for those with severe allergies.

“I have seen the look of worry or fear,” she remarked, sharing her experience about her 11-year-old son with multiple food allergies.

Neffy’s needle-free administration is especially beneficial for children who fear injections. Statistics suggest that around 3,500 caregivers accidentally injure themselves with auto-injectors annually.

Priscilla Hernandez from Pasadena, California, shared how her son, Zacky, was traumatized by an auto-injector incident at school. The FDA approval has given them hope for a less traumatic future.

Epinephrine, first marketed in 1901, has a long history. Auto-injectors like EpiPen, which was approved in 1987, weren’t initially required to prove safety and efficacy through clinical trials.

ARS Pharmaceuticals conducted comparative studies on Neffy, showing it worked effectively by boosting heart rate and blood pressure, comparable to injected epinephrine. The nasal spray is combined with a patented agent to ensure absorption through nasal membranes.

There are other needle-free alternatives in development. These include nasal sprays from Bryn Pharma and Nausus Pharma, a needle-free auto-injector from Crossject, and an epinephrine film from Aquestive Therapeutics.

Richard Lowenthal, president and CEO of ARS, emphasized Neffy’s ease of use, especially for children. “There’s no needle, there’s no pain,” he said. “It’s basically like spraying saline into your nose.”

Neffy will be available in packs of two, expected to be priced similarly to auto-injectors, around $300 to $700. Insurance coverage for the device remains a hopeful factor for reducing costs to patients.