Adamis Pharmaceuticals Announces Publication of a New Human Factors Study Comparing Its Symjepi™ Epinephrine Prefilled Syri...
08 Marzo 2018 - 8:00AM
Adamis Pharmaceuticals Corporation (NASDAQ:ADMP) (“Adamis”) today
announced that a study titled “Human Factors Study in Untrained
Adolescents Comparing Its Epinephrine Prefilled Syringe (Symjepi™)
with EpiPen® Auto-Injector” was recently published in the Annals of
Allergy, Asthma and Immunology.
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.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “This
study demonstrates the ease of using Symjepi™. We believe
Symjepi™ will provide a small, non-threatening, intuitive
alternative to the market-leading auto-injectors.” 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.”
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 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 for human and veterinary use, 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.
Contacts: Mark Flather Senior Director,
Investor Relations& Corporate Communications Adamis
Pharmaceuticals Corporation (858)
412-7951mflather@adamispharma.com
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