A once-recalled epinephrine device will be back in 2017 with more than 100 safety checks—and hopefully an affordable price tag.
Here's some welcome news for anyone with severe allergies longing for another option besides the famously overpriced EpiPen: Auvi-Q is coming back on the market in the United States in the first half of 2017, according to its maker, Kaléo.
You may remember that the device was voluntarily recalled in 2015 due to concerns that it could potentially administer an incorrect dose of the life-saving hormone epinephrine (no deaths were reported).
At that time, the high-tech product—lauded for talking you through the proper injection process—was licensed out to rival French pharma company Sanofi. But in February of 2016, Kaléo regained control of the device and implemented manufacturing safety measures, including a robotic production line with more than 100 automated quality checks.
Still, as a parent of a nut-allergic child (one who weirdly enough had the Auvi-Q when it was recalled), my worry is: Am I sure I can trust this product to deliver the correct dose?
That's the question I put to the inventors of Auvi-Q, twin brothers Evan and Eric Edwards, an engineer and physician who are VPs with Kaléo. After telling me about their state-of-the art manufacturing process, Evan shares the company's backstory: "My brother Eric and I are severe allergy sufferers and parents of allergic children. We take the quality and manufacturing of this product very, very seriously because it's personal for us."
In fact, it was their own experience growing up allergic to almost everything that drove them to invent the device, Eric adds. "Evan and I, when we were 3, were labeled as some of the most allergic children our physician had ever encountered. We grew up allergic to all eggs, peanuts, tree-nuts, seafood, fish, shellfish, most antibiotics, all insect venom."
"Back in the 80s, there was not a lot of awareness. We were were those kids that had to sit alone at a table, because there wasn't a peanut-free zone back then." They had epinephrine with them at all times, but once they were college age, Eric admits, "We struggled to carry it. Our whole goal was to create a different option."
Different how? Well smaller, for one: Auvi-Q is the size of a credit card and the thickness of the average cell phone. The sleek design isn't for looks but rather to increase the odds that it will be carried everywhere. "Unfortunately, I've had to respond to my own child having an anaphylactic reaction," Eric says. "It doesn't matter what epinephrine device you have, if it's not readily available with you and it's not used correctly during that moment, it could be tragic."
RELATED: Your 12 Worst Allergy Mistakes
The step-by-step voice instruction walks you through what to do in the moment, including where to place the device (the thigh; like the EpiPen, it's an intra-muscular injection) and how many seconds to hold in place before removing (5 seconds with Auvi-Q). "It's about empowering people, even ones that are untrained like a neighbor or babysitter, to be able to manage that emergency situation," Eric says.
Because the fact is, you might not be with your child when a reaction occurs. I can't even count how many times I've dropped my son at a party or soccer practice and handed the "EpiPen" to a terrified-looking mom or dad while instructing them to jab my kid in the thigh in the case of emergency. I've left and panicked: What are the chances they'll remember that?
Another safety innovation is a fully-retractable needle, designed to prevent the needle from breaking off and getting embedded in a squirming child's leg. Other epinephrine auto-injectors are required by the FDA to include safety warnings that this could happen, according to the Edwards brothers, but Auvi-Q is not because there have never been any reported cases.
As for the million-dollar question (or, rather, the $600 question): Are Auvi-Q's going to cost $600? "We understand that price is central," says Spencer Williamson, President and CEO of Kaléo. "Our focus is to assure that the out-of-pocket to the patient will be low."
It's comforting to know, at least, that they have reason to not cut corners. As Evan says, "We are manufacturing with this in mind: We may have to use it on our own child one day."