Adamis announced the publication of a peer-reviewed study on the use of Symjepi (epinephrine) prefilled syringe compared with EpiPen (epinephrine; Mylan) prefilled auto-injector in untrained adolescents. The findings have been published in the Annals of Allergy, Asthma and Immunology.
The human factors study entitled “Human Factors Study in Untrained Adolescents Comparing Its Epinephrine Prefilled Syringe (Symjepi) with EpiPen Auto-Injector,” enrolled 34 adolescents aged 12 to 17 years old who had no familiarity with an epinephrine device (naive) and did not receive training during the study. Study patients were randomized to 1 of 2 cohorts: one group was given Symjepi devices first to inject, then asked to attempt a second injection with EpiPen devices whereas the second group was given EpiPen devices first, then asked to attempt a second injection with Symjepi devices.
Of the total injection attempts, there were no errors associated with Symjepi use compared with 4 errors seen with EpiPen. All study patients successfully simulated an epinephrine injection with Symjepi whereas 3 patients incorrectly injected their thumb. Researchers pointed out that the 12% error rate observed with EpiPen in this study was comparable to the 11% use error rate seen in a previous study of untrained adolescents.
Dr. Ronald Moss, Chief Medical Officer of Adamis, added, “The correct use of a device with epinephrine is critical to effectively treating a life-threatening episode. This prospective human factor study supports the ease and correct use of Symjepi for the acute treatment of anaphylaxis.”
Symjepi was approved by the Food and Drug Administration (FDA) in June 2017 for the treatment of allergic reactions (Type 1) including anaphylaxis. It is supplied as a single-dose, pre-filled syringe for manual injection, containing 0.3mg/0.3mL epinephrine sterile solution for injection in 1- or 2-count packs.
For more information call (858) 997-2400 or visit AdamisPharmaceuticals.com.