FDA approves voice-guided emergency anaphylaxis treatment

The FDA recently approved Auvi-Q, an epinephrine auto-injector for the emergency treatment of allergic reactions, according to a press release.

Auvi-Q (Intelliject Inc.) is intended for patients with a history of or who are at risk for anaphylaxis. The device, which the release describes as roughly the size of a credit card with the thickness of a cellular phone, provides step-by-step instructions in the form of audio and visual cues to help the user through the injection process. Users receive a five-second countdown to injection and a light signal upon completion, and the needle retracts automatically into the device to prevent accidental punctures.

The device is available in dosages of 0.3 mg, intended for patients weighing 66 pounds or more, and 0.15 mg, for patients weighing between 33 and 66 pounds. Each package includes two devices, each with one epinephrine dose, along with an non-active training device.

Injection should be performed only in the outer thigh. Potential side effects include increased heart rate, strong or irregular heartbeat, sweating, nausea and vomiting, difficult breathing, weakness, headache and anxiety, among others, according to the release.

Sanofi US has commercialization rights to the device for North America, and Intelliject retains the rights for the rest of the world.

“With this FDA approval, Auvi-Q will become the first-and-only epinephrine auto-injector that talks users through each step of the injection process,” Bryan Downey, vice president, Auvi-Q, Sanofi US, said in the release. “We are confident that Auvi-Q will provide the up-to six million Americans at risk for anaphylaxis and their caregivers an easy-to-use, compact option with unique features to help manage a life-threatening allergic reaction.”