Adamis Pharmaceuticals’ new epinephrine injection device, Symjepi, made waves last June when it received approval from the FDA. In comparison to its competition – the ubiquitous EpiPen – Symjepi is a single-dose pre-filled syringe, not an auto-injector device. This means that the user manually unsheathes the needle and deploys the plunger to administer the dose of epinephrine. With this unique design, Symjepi promised investors and patients a smaller, more user-friendly product – at a lower price.
Eight months after FDA approval, the company recently announced that it is in late-stage talks with two potential marketing partners and that the launch of the Symjepi is imminent. But how will Symjepi fare in a market dominated by the EpiPen? At the 2018 Joint Congress of the American Academy of Allergy, Asthma and Immunology (AAAAI) and World Allergy Organization (WAO), Adamis CMO Ronald Moss presented data from a prospective human factors validation study, which shed some light on how Symjepi might indeed improve the lives of patients.
Symjepi’s human factors study
When evaluating a new medical device, human factors studies are crucial to identifying possible issues resulting from incorrect use and device failures. The prospective study by Adamis enrolled 82 participants, all of whom represented different types of potential epinephrine users: adults, adolescents, and lay caregivers either with or without previous epinephrine injector experience.
During the study, only half of the participants in each user group were trained to use Symjepi. Trained and untrained participants were then given the device and told to simulate having an anaphylactic episode. Participants were assessed for the completion of critical tasks for the proper administration of epinephrine, such as retrieving the syringe or inserting needle into the thigh. Only one user (1.2%) failed to completely push the plunger down on the syringe, thus not successfully administering the product.
There was some confusion regarding the location of the injection—several users injected into the forearm, deltoid, bicep, triceps, or hip instead of the thigh. However, these were not considered treatment failures because the dose would still have been administered to a large muscle. This study suggests that Symjepi is easy to use in both trained and untrained users with a range of familiarity with epinephrine injection devices.
Though the presentation at the 2018 AAAAI/WAO Joint Congress lacked a head-to-head comparison of Symjepi to the EpiPen – these data are still forthcoming – a small study released by Adamis at the end of February in the Annals of Allergy hints toward what the comparison might look like. In this study of 34 untrained adolescents asked to simulate an anaphylactic episode, all participants used Symjepi correctly, while four users made significant errors when administering the EpiPen. Specifically, three users made the injection with the thumb over the needle port (meaning that the dose would have been administered to the finger) and one other user failed to hold the EpiPen on the thigh for the correct amount of time. Though the Symjepi is ultimately a simpler delivery method, it is possible that having the needle visible and requiring manual deployment of the syringe provide key visual cues that make using the device more intuitive.
Though these usability data are promising and may help distinguish Symjepi from EpiPen, the true defining factor for Symjepi’s success will likely be its price – information that will not be released until its launch.