SAN DIEGO, March 06, 2018 — 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.”
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company focused on developing and commercializing products in the therapeutic areas of respiratory disease and allergy. The company’s first product, Symjepi (epinephrine) Injection 0.3mg, was approved in June 2017 for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis’ product pipeline includes HFA metered dose inhaler and dry powder inhaler products for the treatment of bronchospasm and asthma.
The Company’s U.S. Compounding, Inc. (USC) subsidiary, which is registered as a drug compounding outsourcing facility under Section 503B of the U.S. Food, Drug & Cosmetic Act and the U.S. Drug Quality and Security Act, compounds sterile prescription drugs, and certain nonsterile drugs, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.
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 SEC, which Adamis strongly urges you to read and consider, all of which are available free of charge on the SEC’s web site at http://www.sec.gov. Any forward-looking statement in this press release speaks only as of the date on which it is made. Except to the extent required by law, Adamis expressly disclaims any obligation to update any forward-looking statements.
Senior Director, Investor Relations
& Corporate Communications
Adamis Pharmaceuticals Corporation