SOUTHFIELD, Mich. (WXYZ) — It’s very unusual that the FDA does not follow the advisory committee’s recommendation. However, a significant cause for concern was the lack of clinical data.
The drug, called Neffy, is an epinephrine nasal spray, but it was not studied in people experiencing anaphylaxis. Anaphylaxis is a severe and potentially life-threatening allergic reaction. It needs to be treated immediately with epinephrine, which is given via an autoinjector like EpiPen.
ARS Pharmaceuticals said that the nasal spray was "comparable" to an EpiPen, based on studies conducted in both animals and individuals who did not experience anaphylaxis.
Conducting a proper randomized controlled clinical trial in this case would be unethical. In these trials, people either receive the drug or a placebo. However, anaphylaxis can be deadly if left untreated. It triggers the immune system to release a flood of chemicals. You can experience hives, wheezing, swelling of the mouth, throat, or tongue, difficulty breathing, and, in some cases, loss of consciousness. So, testing new drugs on people who could potentially die due to a placebo or a potentially ineffective drug is simply unacceptable.
The FDA has requested the company do further testing. Specifically, a study involving repeat doses under allergen-induced allergic rhinitis conditions. This means repeat doses of the nasal spray would be compared to repeat doses of an autoinjector. Symptoms would include sneezing, itching and congestion.
The company plans to resubmit its application in the first half of 2024.
I am hopeful that the new data will show that the nasal spray is effective. Because I know a lot of people, including many of my patients, who are afraid of needles. They can be scary and intimidating, causing some folks to hesitate or wait before administering the life-saving medication.
One study found that roughly 3.3 million people have an epinephrine autoinjector prescription, but only about half regularly carry it. And that is very concerning.
I think a nasal spray would be easier for many people, especially families with young children. But while I’m all for a nasal spray, we definitely want to make sure that it’s effective, works properly, and saves lives.
