Adamis Pharmaceuticals to Fund ZIMHI® Clinical Study with University of Leiden Opioid Expert
July 28 2023 - 7:30AM
Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a
commercial-stage biopharmaceutical company, today announced the
Company has committed to fund an unrestricted research grant to the
Leiden University Medical Center (LUMC) Anesthesia and Pain
Research Unit. The funding will support the work of Albert Dahan,
MD, PhD, a world expert on opioid-induced respiratory depression
(opioid overdose) and professor of anesthesiology at the
University. Dr. Dahan has been working with the FDA since 2020 to
understand better methods of reversing fentanyl overdoses.
“Data presented from our recent study conducted in collaboration
with the U.S. Food and Drug Administration (FDA) indicated that
faster and higher blood concentrations of naloxone are most
effective in reversing overdoses from higher strength opioids, such
as fentanyl,” said Dr. Dahan. “The objective of this collaboration
with Adamis will be to assess the efficacy of 5mg intramuscular
ZIMHI versus 4mg of intranasal naloxone, which is comparable to
NARCAN® and the respective number of doses required to reverse
fentanyl-induced respiratory depression.”
The prior study data referenced above by Dr. Dahan was presented
in a summary report released by the Reagan-Udall Foundation of the
FDA in March, which states that, “The most recent rise in overdose
deaths is primarily driven by fentanyl and fentanyl analogs.” The
summary goes on to highlight that “higher naloxone doses (than the
current standard of care) may be required for an initial reversal
of respiratory depression due to fentanyl."1
Eboo Versi, MD, PhD, CEO of Adamis, said, “These data from the
FDA are supported by what we are hearing from first responders
having to deal with fentanyl overdoses and poisoning, and this has
resulted in tragic consequences.”
“Narcan is the standard of care to reverse an opioid overdose,
but with fentanyl we are needing to use about three doses to
achieve recovery,” said David B. Rausch, Director of the Tennessee
Bureau of Investigation.
Samuel P. Chapman, Director of Parents for Safer Children,
stated, “Prescription strength ZIMHI is the best remedy available
for opioid overdose. If we had had some in the house when our son
Sammy died, he would still be with us.”
“We believe that if ZIMHI demonstrates superiority in reversing
fentanyl-induced respiratory depression in patients in the LUMC
clinical study, national health organizations will update their
emergency protocols to include the use of ZIMHI,” stated Dr. Versi.
“Given the increased incidence of fentanyl poisoning, especially
when combined with xylazine, there is now a need for a treatment
that quickly results in high blood levels of naloxone as effected
by ZIMHI. I believe that all first responders and harm reduction
groups should have ZIMHI in their toolbox.”
About ZIMHI®
ZIMHI (naloxone HCl injection) is an FDA-approved, intramuscular
injection of the highest available dose and concentration of
naloxone that can rapidly enter the bloodstream for the emergency
treatment of opioid overdose (also known as opioid induced
respiratory depression). ZIMHI is available with discounted public
interest pricing for first responders and other community health
organizations, with additional information available via email to
ZIMHIPublicHealthInfo@usworldmeds.com or at
www.zimhi.com/public-service/.
1
https://reaganudall.org/sites/default/files/2023-03/Understanding%20Fatal%20Overdoses_Slides_Day%201.pdf
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a commercial stage
neuro-biotech company primarily focused on developing and
commercializing products for the treatment of opioid overdose and
substance use disorders. Adamis’ commercial products approved by
the FDA include ZIMHI® (naloxone) Injection for the treatment of
opioid overdose, and SYMJEPI® (epinephrine) Injection for use in
the emergency treatment of acute allergic reactions, including
anaphylaxis. As a result of its recent merger transaction with DMK
Pharmaceuticals, the Company is now focused on developing novel
therapies for opioid use disorder (OUD) and other important
neuro-based conditions where patients are currently underserved.
The Company believes its technologies are at the forefront of
endorphin-inspired drug design with its mono, bi- and
tri-functional small molecules that simultaneously modulate
critical networks in the nervous system. Adamis has a library of
approximately 750 small molecule neuropeptide analogues and a
differentiated pipeline that could address unmet medical needs by
taking the novel approach to integrate with the body’s own efforts
to regain balance of disrupted physiology. The Company’s lead
clinical stage product candidate, DPI-125, is being studied as a
potential novel treatment for OUD. Adamis also plans to develop the
compound for the treatment of moderate to severe pain. The
Company’s other development stage product candidates include
DPI-221 for bladder control problems and DPI-289 for severe end
stage Parkinson’s disease. For additional information about Adamis
Pharmaceuticals, please visit our website and follow us on Twitter
and LinkedIn.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements are identified by terminology such
as “may,” “should,” “expects,” “plans,” “anticipates,” “could,”
“intends,” “target,” “projects,” “contemplates,” “believes,”
“estimates,” “predicts,” “potential” or “continue” or the negative
of these terms or other similar words. Such forward-looking
statements include those that express plans, anticipation, intent,
contingencies, goals, targets or future development and/or
otherwise are not statements of historical fact. These statements
relate to anticipated future events or future results of
operations, including, but not limited to, statements concerning
(i) the creation of federal guidelines to remove barriers to access
opioid reversal products at the state and local levels, (ii) the
likelihood of passage of congressional legislation designed to
improve access to naloxone for stakeholders, and (iii) the
effectiveness of ZIMHI in reversing the effects of opioid overdose
and to reverse fentanyl induced respiratory depression and prevent
cardiac arrest. 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
the results anticipated by such forward-looking statements.
Accordingly, you should not rely upon forward-looking statements as
predictions of future events. Adamis cannot assure you that the
events and circumstances reflected in the forward-looking
statements will be achieved or occur, and actual results could
differ materially from those projected in the forward-looking
statements. You should not place undue reliance on any
forward-looking statements. Further, any forward-looking statement
speaks only as of the date on which it is made, and except as may
be required by applicable law, we undertake no obligation to update
or release publicly the results of any revisions to these
forward-looking statements or to reflect events or circumstances
arising after the date of this press release. Certain of these
risks and additional risks, uncertainties, and other factors are
described in greater detail in Adamis’ filings from time to time
with the SEC, including its annual report on Form 10-K for the year
ended December 31, 2022, and subsequent filings with the SEC, which
Adamis strongly urges you to read and consider, all of which are
available free of charge on the SEC’s website at
http://www.sec.gov.
Contact:Adamis Investor RelationsRobert UhlManaging DirectorICR
Westwicke619.228.5886
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