By Kristen Chandler
As a parent of a child with severe food allergies, I know how important epinephrine is. In fact, a few months ago I had to use my son’s EpiPen on him for the first time.
For several years, we have had a prescription for EpiPens. We’ve kept them on hand and then disposed of them because we hadn’t used them and they expired. On that day a few months ago—especially during the ten seconds I held that injector in his leg—I was so grateful to have his EpiPen. Some people aren’t as fortunate.
The most commonly prescribed form of epinephrine is the EpiPen. And it makes sense, because the EpiPen contains a premeasured dose of epinephrine in a convenient and, for the most part, easy-to-use injector. However, purchasing an EpiPen isn’t as convenient as using one. The EpiPen comes in a two-pack, which now costs between $600-$700. Even after insurance, most people are still paying around $300-$400. In addition to the already high cost, the shelf life of an EpiPen is a little over a year, so they have to be replaced annually. And epinephrine is an “as needed” drug, so a lot of families are buying and disposing of unused EpiPens like we have. In some cases, the outrageous price of epinephrine has driven some people to desperate measures. Some have chosen to simply do without and do their best to avoid their allergen(s). Some parents only get one two-pack and keep one EpiPen at school and the other at home, although it’s recommended to always carry two injectors in the event that one pen is defective or one dose is not enough. Some are getting prescriptions for just epinephrine and a needle, instead of the expensive injector. News of a generic EpiPen and cheaper alternative injectors are welcome distractions.
However, one scientist has been working on a different approach: an epinephrine pill. If approved, this epi-pill could eliminate the need for an EpiPen injector. An epinephrine in pill form would be more convenient to carry around than injectors. The shelf life would also be longer than one year, meaning the pills wouldn’t have to be replaced as often as unused injectors. And the price? The lead researcher working on the epinephrine pill, Mutasem Rawas-Qalaji, says the decision of cost will ultimately fall upon the manufacturer who decides to take on the pill. But Rawas-Qalaji is hopeful that the price will be “affordable and make sense.”
One reason why epinephrine hasn’t been presented in pill form earlier is because when ingested, epinephrine breaks down in the stomach and liver before it hits the bloodstream, and it needs to hit the bloodstream in order to be effective. Rawas-Qalaji and his team designed a dissolvable pill, commonly called an orally disintegrating tablet (ODT) and most often used by people who have trouble swallowing pills. Instead of being placed on top of the tongue like most ODTs, the epi-pill would be held under the tongue until it dissolved. And because it would be dissolved under the tongue instead of on top, the epinephrine would still go straight to the bloodstream, eliminating the digestive tract. Since the pill dissolves so quickly, some of the drug does get lost in the process, so the epinephrine pill contains about 20 mg of epinephrine as opposed to the 0.3 mg that an EpiPen contains.
There is a downfall to an epinephrine pill, though. To find out if it would be effective or not, the pill would have to be tested on someone actually having an anaphylactic reaction. The result of the pill not working could be fatal. Rawas-Qalaji is aware of that, and he is also aware that people won’t exactly be lining up to be exposed to their allergens to try an experimental drug. His approach will be to give the pill to volunteers who are healthy, and then measure the hormone concentration in their blood. Then he would compare this to blood samples from people who have received an epinephrine injection. If the samples match, this would mean that the epi-pill should be effective in stopping an anaphylactic reaction.
Another drawback is that a mouth swollen from a reaction may not process the pill the same way that a healthy mouth would. Rawas-Qalaji has discussed this as well as other concerns with the FDA. He also said that his team would be ready to begin a clinical trial within a few years. They would be working closely with an allergist and the FDA. Mylan’s patents for the EpiPen expire in 2025, and Rawas-Qalaji is optimistic that his epinephrine pill will gain FDA approval much sooner than that.
So, while this is exciting news, it’s still early and there will be a long road of testing ahead before we actually see an epinephrine pill on the market. But it is still a medical advancement worth following.
What do you think? Is an epi-pill the future of allergy treatment? We’d love to hear your thoughts.