SAN DIEGO, March 27, 2018 /PRNewswire/ -- Imprimis
Pharmaceuticals, Inc. (NASDAQ: IMMY), an ophthalmology-focused
pharmaceutical company, today announced it has secured a patent
covering the company's innovative MKO (midazolam, ketamine, and
ondansetron) Melt® compounded formulation from the US Patent and
Trademark office. US Patent 9,918,993 B2 entitled
"Pharmaceutical compositions for anesthesiological applications"
was issued on March 20, 2018.
Mark L. Baum, CEO of Imprimis,
stated, "We are pleased to have been granted this patent which
covers our MKO Melt® formulation and a variety of other versions of
midazolam and ketamine combinations we intend to make available to
address unmet patient needs. Since we first made the MKO Melt
available in 2015, it has been dispensed as a compounded
formulation over 70,000 times, used primarily prior to and during
cataract surgery." John
Berdahl, MD, board-certified ophthalmologist and inventor of
the MKO Melt, added, "We have completed more than 10,000 cataract
surgeries using the MKO Melt and have had great success with
it. We have found that it offers unique benefits to patients
who may not be well suited for traditional IV sedation. I am
pleased it is now protected by this newly issued patent, and
potentially, other procedural sedation patent applications that
remain pending."
Imprimis believes that beyond cataract surgery, there are likely
more than 100 million annual procedures in the US ranging from
dental, obstetric and gynecological, medical imaging procedures
(such as MRIs and CAT scans), vasectomies, colonoscopies,
dermatological, plastics procedures, orthopedic, otolaryngological,
podiatry, emergency room, urology, and psychiatric that may benefit
from an IV-free and opioid-free formulation.
MKO Melt Clinical Studies
Imprimis' MKO Melt compounded formulation is the subject of two
IRB-approved clinical studies. The first is a prospective,
three arm, randomized double blind investigator initiated study of
724 total patients undergoing cataract surgery. This study
has been completed and the manuscript and accompanying data is
being prepared for submission for peer-review. The second is
a National Institutes of Health (NIH) funded prospective randomized
double-blinded study that will follow patients receiving cataract
surgery with either traditional IV anesthesia or oral anesthesia,
evaluate their comfort ratings, then determine if their comfort
correlates to the type of anesthesia they received. This
study, which is expected to be completed in 2018, is being
conducted by a major midwestern US healthcare system. A third
study, related to the pharmacokinetics of the MKO Melt, is being
planned for completion during 2018.
For more information and to order the MKO Melt compounded
formulation, please visit www.IVFree.com.
For more information about procedural sedation, please visit
here.
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is dedicated to
making high quality innovative medications accessible and
affordable in all 50 states. The company's flexible business
model allows a drug to be compounded or developed as an
FDA-approved product through one of its subsidiaries or spin-out
companies. For more information about Imprimis, please visit
the corporate website at www.ImprimisRx.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995. Any statements in this release that are not historical facts
may be considered such "forward-looking statements."
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the
statements contained herein. Some of the potential risks and
uncertainties that could cause actual results to differ from those
predicted include our ability to make commercially available our
compounded formulations and technologies in a timely manner or at
all; physician interest in prescribing our formulations; risks
related to our compounding pharmacy operations; our ability to
enter into other strategic alliances, including arrangements with
pharmacies, physicians and healthcare organizations for the
development and distribution of our formulations; our ability to
obtain intellectual property protection for our assets; our ability
to accurately estimate our expenses and cash burn, and raise
additional funds when necessary; risks related to research and
development activities; the projected size of the potential market
for our technologies and formulations; unexpected new data, safety
and technical issues; regulatory and market developments impacting
compounding pharmacies, outsourcing facilities and the
pharmaceutical industry; competition; and market conditions. These
and additional risks and uncertainties are more fully described in
Imprimis' filings with the Securities and Exchange Commission,
including its Annual Report on Form 10-K and its Quarterly Reports
on Form 10-Q. Such documents may be read free of charge on the
SEC's web site at www.sec.gov. Undue reliance should not be placed
on forward-looking statements, which speak only as of the date they
are made. Except as required by law, Imprimis undertakes no
obligation to update any forward-looking statements to reflect new
information, events or circumstances after the date they are made,
or to reflect the occurrence of unanticipated events.
Imprimis's MKO Melt is a compounded formulation and not
FDA-approved. Other than drugs compounded at a registered
outsourcing facility, all Imprimis compounded formulations require
a prescription for an individually identified patient consistent
with federal and state laws.
Investor Contact
Jon
Patton
jpatton@imprimispharma.com
858-704-4587
Media Contact
Deb Holliday
Holliday Communications, Inc.
deb@hollidaycommunications.net
412.877.4519
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SOURCE Imprimis Pharmaceuticals, Inc.