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Tuesday, March 06, 2018 1:12:54 PM
Adamis Pharma Highlights Excerpts From Abstract Of Presentation 'Human Factors Study of A Newly Approved Epinephrin...' At AAAAI Congress
Today 9:11 AM ET (Benzinga)Print
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today provided an update on data from its presentation entitled “Human Factors Study of A Newly Approved Epinephrine Prefilled Syringe (Symjepi) for the Emergency Treatment of Allergic Reactions (Type I) Including Anaphylaxis”. The presentation took place at the American Academy of Allergy, Asthma, and Immunology (AAAAI) joint congress with the World Allergy Organization in Orlando, Florida on March 3, 2018.
Excerpts from the presentation’s Abstract were as follows:
Introduction: Epinephrine remains the treatment of choice for acute anaphylaxis. However, currently available auto-injectors are costly, and studies have demonstrated human factor issues resulting in incorrect use (lacerations) as well as device failures. Correct auto-injector use has been noted to be as low as 20% in some studies. A recently FDA approved prefilled syringe of epinephrine for the treatment of anaphylaxis (Symjepi™) was examined in a prospective human factors validation study in order to determine the likelihood that the product would be used safely and effectively by intended users.
Methods: A total of 82 participants were enrolled in this prospective study including adults with and without epinephrine injector experience, adolescents with and without epinephrine injector experience, and lay caregivers with and without epinephrine injector experience. Half of the participants in each user group were trained to use Symjepi™ prior to first use in the study. Critical tasks that could cause harm and compromise the successful use of epinephrine were assessed and included five categories: Open the case (I), retrieve prefilled syringe (II), remove needle cap (III), insert needle in the thigh (IV), press plunger until it stops (V).
Results: 100 % (82/82) of participants were able to complete task I. 100% (82/82) of participants completed task II. 100% (82/82) were able to complete task III. 93% (77/82) completed task IV and 99% (81/82) completed task V.
Dr. Ronald Moss, Chief Medical Officer at Adamis and a Fellow of AAAAI stated, “Human factor studies are important to support the safe and effective use of epinephrine devices used in the treatment of anaphylaxis. This prospective human factor study for this epinephrine device supports the ease and correct use of Symjepi™ for the acute treatment of anaphylaxis. Symjepi™ is a newly approved epinephrine syringe for the treatment of anaphylaxis and should provide a good cost-effective user-friendly alternative to current auto-injectors.”
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