SymjepiTM, a prefilled syringe containing epinephrine for the treatment of anaphylaxis, fared well when compared to the market leader in this published, peer-reviewed study. Human factor studies are very useful to test devices in order to approximate their correct or incorrect use in real situations and in different populations. A human factors study was conducted post-approval to compare the correct use of Symjepi™ compared to EpiPen® in untrained adolescents. Participants were aged 12 to 17 years old, had no familiarity with an epinephrine injector device (naïve) and were not trained during the study. There were 17 male and 17 female subjects with a mean age of 14.7 years.
The participants were randomized into two groups (cohorts) of 17. In the first cohort, participants were provided Symjepi™ devices and asked to imagine experiencing symptoms that required an immediate injection of epinephrine. After simulating an injection with Symjepi™ devices, participants were provided EpiPen® devices and asked to attempt a second injection. Participants in the second cohort were provided EpiPen® devices first, then asked to attempt a second injection with the Symjepi™ devices.
Among all injection attempts, there were no use errors for the Symjepi™ device (0/34). All 34 participants successfully completed all steps in order to simulate an epinephrine injection with the Symjepi™ device. However, a total of four errors (4/34) were observed for the EpiPen® with three of four incorrectly injecting their thumb. All four errors were considered critical use errors that could have a negative impact on the effective treatment of anaphylaxis.
The 12% error rate for participants attempting to use EpiPen® in this study was similar to the use error rate observed in another published study of untrained participants which had an 11% failure rate. It is noteworthy to understand why untrained adolescents were used in this study. This is the largest population of fatalities caused by anaphylaxis due to foods. Food allergies contribute to as many as 70% of all food related deaths. Therefore, proper use of epinephrine injection devices is of paramount importance in this age group.
Adamis Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future results of operations, including, but not limited to the following statements: the status of anticipated presentations by the company at upcoming conferences; the company's beliefs concerning the ability of its products and product candidates to compete successfully in the market; the company’s beliefs concerning the results of studies relating to Symjepi and user perceptions of Symjepi; and the company's beliefs concerning the safety and effectiveness of its products and product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause Adamis' actual results to be materially different from those contemplated by these forward-looking statements. Certain of these risks, uncertainties, and other factors are described in greater detail in Adamis’ filings from time to time with the
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Source: Adamis Pharmaceuticals Corporation