FDA Committee Recommends Epinephrine Nasal Spray for Severe Allergic Reactions
The Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee voted on May 11 to recommend an epinephrine nasal spray product for the treatment of severe allergic reactions, including anaphylaxis.
The 22-member advisory committee voted 16–6 to recommend approval of the 2 milligram epinephrine saline-based spray, marketed as Neffy, for adults.
It voted 17–5 to recommend the spray for children who weigh more than 30 kilograms—about 66 pounds—concluding that available data support “a favorable benefit-risk assessment” of the spray.
If approved, Neffy, developed by biotechnology company ARS Pharmaceuticals, will become the first needle-free epinephrine product for the treatment of severe allergic reactions.
In a press release, Richard Lowenthal, president and CEO of ARS Pharmaceuticals, said that data stemming from clinical trials conducted among more than 600 individuals show that Neffy’s absorption-enhancing nasal spray technology is “comparable to injectable products in delivering potentially lifesaving epinephrine” but has the added advantage of being small, needle-free, and conveniently sized.
During various trials, adults and children who weighed 66 pounds or more received at least one dose of Neffy, according to ARS Pharmaceuticals.
The results showed similar epinephrine levels in the blood compared to intramuscular injection, including the first 10 to 20 minutes when the clinical response was observed, the company said.
Results also showed similar or greater systolic blood pressure and heart rate in patients compared to intramuscular injection even 1 minute after receiving the dose of Neffy, and the nasal spray worked effectively even when patients had nasal congestion or runny nose due to conditions such as allergic rhinitis or upper respiratory tract infection, ARS Pharmaceuticals said.
FDA Weighing Approval
Additionally, the company noted the spray came without “any meaningful nasal irritation or pain” and has the benefit of removing needle-related risks.
Overall, data showed that the nasal spray was well tolerated. Side effects were mild and did not include nasal problems, the company said.
However, separate data (pdf) shows that some side effects from the spray included vomiting, dizziness, a decrease in heart rate, headaches, faintness, a decrease in blood pressure, and physical weakness in a small number of patients.
Additionally, some members of the Pulmonary-Allergy Drugs Advisory Committee raised concerns that the clinical trials were conducted on healthy individuals or those suffering from milder allergic reactions as opposed to those with severe allergic reactions, due to safety reasons.
The FDA is expected to make a decision on whether to approve the drug this year, although it is not legally required to follow votes by the Pulmonary-Allergy Drugs Advisory Committee.
ARS Pharmaceuticals told investors in March that it hopes to launch the prescription spray by the end of the year.
More than 100 million people in the United States experience various types of allergies each year, according to the Asthma and Allergy Foundation of America.
“Millions of people have been waiting decades for a new delivery method of epinephrine, and we are grateful to the community for sharing their personal experiences and illustrating the potential Neffy has in changing lives,” Lowenthal said in the May 11 press release.
“We continue discussions with private payers, pharmacy benefit managers, and retail pharmacies to ensure that if Neffy receives FDA approval, we are ready to make this important new treatment modality widely available for those who need it,” he added.
