By Dr. Larry Chiaramonte
A company has announced a successful feasibility study for delivering epinephrine in the form of a nasal inhaler. According to a press release, the study by Shin Nippon Biomedical Laboratories, Ltd “demonstrated that this needle-free nasal epinephrine formulation succeeded in achieving rapid absorption in peripheral blood comparable to EpiPen™, the leading injectable product.”
However, we have to ask, just because this can be done, does that mean it should be done? I’m all for competition in the pharmaceutical marketplace. EpiPen™ now has a legitimate competitor, the “cool” auto-injector, Auvi-Q™, which packages this life-saving medication in new trappings that encourage more people to carry it and more people to administer it correctly. EpiPen has answered with lower prices. So what does a nasal inhaler have to offer, aside from theoretical relief from needle phobia both for patients and people who have to inject them? Is that really a market niche?
This begs several questions:
1) What do you do with a kid who’s having anaphylaxis with a nose full of mucus? This is not an unusual circumstance in a world where people who have one kind of allergy tend to have others. Do you do first-aid picking preparatory to giving a medication under circumstances in which every second counts?
2) Are people who are squeamish about needles going to have the presence of mind to use an inhaler properly, especially if the patient’s blood pressure is crashing and they are panicking? Will the patient be able to even follow instructions to breathe deeply through her nose? Will they be able to inhale the full therapeutic dose? The great thing about epi is that if there’s a caregiver present it doesn’t depend on the status of the patient. You deliver the drug to the thigh muscle and the body itself does all the work.
3) Another allergist warns that inhaled epinephrine can damage the nasal membranes over a period of time, a la Neo-Synephrine, which can turn the inside of your nostrils into raw hamburger, and there would be progressively worse absorption. I think this won’t be an issue if people are using it infrequently, and I would hope that anaphylaxis would remain a rare occurrence. I do think it will be problematic for people who use it to boost athletic performance or conceivably find a recreational use–sort of like bungee jumping or skydiving without the big rubber bands or airplanes; they don’t call them adrenaline junkies for nothing.
The field of allergy medicine is full of ideas and products that sound good until they are put into practice. For example, we used to recommend holding off feeding of peanuts and other allergenic foods as a preventative. Now, the opposite holds favor. Montelukast—Singulair™—was touted as an easy alternative to inhaled corticosteroids for controlling asthma until use by a large population proved otherwise; it was not as effective for the full population that tried it, and it had some troubling side effects. More recently sub-lingual immunotherapy (SLIT) has been seen as a painless alternative to allergy shots, but lots of people hate the minor reactions and the taste.
As a Canadian researcher, Paul M. O’Byrne, has pointed out, one of the biggest weaknesses with all medication is the fact that it doesn’t get tested under real-world conditions until it is out in the real world at which point it runs smack into human behavior, not to mention varying phenotypes that respond differently to chemistry. One of those involved in this new nasal enterprise says, “Only a small fraction of diagnosed at-risk anaphylaxis patients carry an auto-injector, which is in part due to needle phobia and lack of training in their use. Our joint product promises to provide patients [and their families] with a needle-free alternative.” I am just guessing, but I would say that needle phobia is a very small part of the picture. It is true that only a fraction of those who should carry epinephrine do so, or receive proper training in their use, but that is the fault of their doctors for not doing more to educate patients.
Building a product around the weaknesses of the established therapies sounds like a lousy idea to me. Let’s treat anaphylaxis with the gravity that a life-and-death situation deserves. Used as directed, both EpiPen™ and Auvi-Q™ deliver life-saving medication exactly where it’s needed in precisely the right dose. Tens of thousands of people do it every year. Sure there are those who recoil at the thought of giving a shot, but I say, grow up! Practice. Take an old EpiPen™ and shoot it into an orange. Use the Auvi-Q™ trainer over and over again. You’re not supposed to think during anaphylaxis, you’re supposed to act. Anyone too squeamish to give epinephrine shouldn’t be in a position of responsibility anyway.
Finally, I wonder how the people behind this idea would feel if they were severely food allergic. Would they want an inhaler shoved in their nose or a shot in the thigh?
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