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Cheaper, longer-lasting epinephrine pills could soon replace overpriced EpiPens

For people with severe allergies, having a ready supply of epinephrine (also known as adrenaline) can be the difference between a mild inconvenience and death. That’s why the recent price hike on the EpiPen auto-injector manufactured by Mylan was such a hot button issue for patients. The company’s CEO, Heather Bresch was subjected to a scolding on Capitol Hill recently, but we might not need to rely upon governmental pressure to keep these life-saving devices affordable much longer. Scientists are close to developing an epinephrine pill.

It has long been the dream of doctors to have a simple pill that can be taken in the event of a severe allergic reaction. However, the realities of the human body have made that difficult. For one, epinephrine is a hormone that would not survive being processed through the stomach. Even if it could survive, it takes time for a traditional pill to be absorbed. Additionally, someone having an extreme allergic reaction might be unable to swallow a pill due to swelling. Anaphylactic shock tends to be an urgent situation where time is of the essence. This is what researchers at Nova Southeastern University in Florida are trying to get around.

With pills not an option, auto-injectors have become the norm, and the EpiPen is often the only model covered by insurance companies. This allowed Mylan to corner the market with its auto-injector, which used to cost $100 for two EpiPens as recently as 2008. Earlier this year the price had risen to $600. Researchers at Nova Southeastern University in Florida are trying to develop an alternative to Epi-Pens that won’t cost anywhere near as much. After all, most of the price is for the fancy injector. The epinephrine itself costs almost nothing.

epipen

To make epinephrine viable as a pill, the team is looking at making it an orally disintegrating tablet or ODT. You’ve probably seen these pills before — they’re meant to be held on or under the tongue until they dissolve. This gets the medicine into the bloodstream almost as quickly as an injection because the mouth (especially under the tongue) is rich in blood vessels. Pills should also have shelf lives of seven years or more, whereas EpiPens need to be replaced every year. It should even work if someone is experiencing swelling from anaphylactic shock. Although, this all requires testing, which is hard to do when you’re talking about severe allergies.

Researchers believe that an epinephrine pill needs to have significantly more active ingredient to match the effects of an injection — perhaps as much as 20mg to an EpiPen’s 0.3mg. Luckily, epinephrine is cheap. Since they can’t intentionally give people with severe allergies anaphylactic shock, researchers will probably have to chart epinephrine levels in healthy people after they take the pill. This system has been used to validate other epinephrine dosages and products. The plan is to get FDA approval for the ODT epinephrine pills long before Mylan’s auto-injector patents expire in 2025.

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