People treating life-threatening allergic reactions with epinephrine injection now have a product that talks them step-by-step through the process.
Auvi-Q (epinephrine injection, USP) is approved by FDA for emergency treatment of allergic reactions in people who are at risk or have a history of anaphylaxis. A single-use, self-disposable autoinjector, Auvi-Q is the first and only compact auto injector with audio and visual cues to guide patients and caregivers through the injection process, says Evan Edwards, vice president for product development, Intelliject (www.intelliject.com
“When someone goes into anaphylaxis, time is of the essence. The patients could be panicked, or often times a caregiver or lay person is administering the injection. It is very important to instill confidence and comfort into the user,” Edwards says.
“Auvi-Q is an empowering device that provides the user with confidence they know how to use it in anaphylactic emergencies,” he adds.
|A single-use, self-disposable autoinjector, Auvi-Q (epinephrine injection, USP) provides step-by-step audio cues to guide the patient or caregiver treating a potentially life-threatening allergic reaction.
Intelliject developed the device and obtained 505-B2 application regulatory approval after testing and a clinical program. A bioequivalence study demonstrated comparable bioavailability with Epipen, which has the same active epinephrine ingredient. Patient groups injected with Auvi-Q and Epipen showed comparable plasma concentration levels.
Sanofi US (www.sanofi.us.com
) has licensed Auvi-Q for manufacturing and commercialization in North America.
A comprehensive human factors engineering process was used to validate the design and user interface. Intelliject sought feedback on device features, forces, and design characteristics from patients, caregivers, and children, from the prototyping stage to final design, Edwards says.
The resulting device features an intuitive design with optimal portability and ease of use.
“We validated the feedback from users with formal studies with patients, caregivers, and healthcare professionals. In head-to-head studies with existing epinephrine auto injectors, we demonstrated the value of the electronic prompt system in mitigating use errors and ensuring users can have success in delivering a potentially life-saving dose of epinephrine,” Edwards says.
Each Auvi-Q pack contains two products containing one dose of epinephrine each, and a demonstration device with no needle or drug. Patients receive one of two doses available based on their weight; 0.3 mg for patients who weigh 66 pounds or more; 0.15 mg for patients weighing 33-66 pounds.
The electronic voice prompts are “task dependent,” immediately moving to the next prompt as the user performs the steps. “You don’t have to wait for the voice instruction to finish in order to go to the next voice instruction,” Edwards says.
The prompt system activates after the user pulls off the outer case, prompting the user to pull off a red safety guard if they are ready to use the device.
The safety guard is on same end as the needle which helps avoid user confusion as to which end is the needle, and also prevents premature activation.
After the safety guard is pulled, the audio instruction tells the user to place the black end of the device firmly against the outer thigh while holding in place for five seconds. When the base pushes upward to activate the product, the voice prompt immediately begins a five-second count down, then indicates the injection is complete, and advises the user to seek emergency medical attention.
Auvi-Q features a unique needle retraction system enabling the five-second hold time.
“All other epinephrine auto-injectors on the market require a use instruction to hold in place for ten seconds. In fact, our needle stays in the muscle for less than one second, compared with other epinephrine auto injectors that have needles that stay in the muscle the whole ten seconds. Our five-second hold time is based on verification and validation testing that show correct drug delivery within the shorter time frame,” he says.
“This is very significant from a usability standpoint as the needle is in the skin and muscle for a shorter duration. In the very stressful situation of an allergic emergency where a parent may be delivering Auvi-Q to a potentially scared, thrashing child, the less time the device needs to be held in place, the better,” Edwards says.