FDA Grants Pre-IND Meeting; Two
Investigator-led Studies on Melt Formulations to Commence in
Q4
Melt Pharmaceuticals, a subsidiary of Imprimis Pharmaceuticals,
Inc. (NASDAQ: IMMY), today announced that following the
presentation of clinical data on the MKO Melt®
(midazolam/ketamine/ondansetron) from a 611-patient IRB approved
prospective, controlled, randomized, three arm comparator study at
the American Academy of Ophthalmology meeting this month,
additional studies on Melt’s drug candidates will soon begin. Both
new studies, along with an upcoming Pre-IND meeting with FDA, which
is scheduled for this coming January, will inform the clinical
development programs Melt expects to begin during 2019.
Pharmacokinetics and Pharmacodynamics of the MK
Melt (Sublingual Midazolam and Ketamine)
The objective of this study is to establish the
pharmacokinetics and pharmacodynamics of midazolam and ketamine
following administration of the patented MK Melt in up to
twenty-five healthy volunteers under an IRB approved protocol with
informed consent. These measurements will identify the time course
of effects of the MK Melt in relation to the concentrations of its
component drugs in the body.
The study will define a window of sedation for
the MK Melt in the volunteers, which will provide vital information
for physicians and anesthesiologists related to the duration and
quality of sedation. Included in the study will be monitoring of
vital signs, blood levels, evaluation of the level of volunteers’
sedation over time, and satisfaction questionnaires completed by
volunteers and study personnel both during and at the conclusion of
the study, which will provide vigorous assessments of the sedation
achieved with the MK Melt. By establishing the time course of its
anesthesia effects, this study should provide data that will allow
anesthesiologists to optimize the timing of administration and
dosing of the MK Melt for different sedation procedures.
This study is expected to be completed during
the fourth quarter of 2018.
Pharmacodynamics of the MKO Melt (Sublingual Midazolam,
Ketamine, and Ondansetron) During Oral Surgery & Dental
Procedures
This multicenter clinical study is designed to
evaluate the safety and efficacy of the MKO Melt for conscious
sedation during dental surgery. There are eight participating sites
with investigators that include leading oral maxillofacial
surgeons, internationally acclaimed pioneers in dental procedures,
and faculty members in dental medicine education from leading
teaching institutions. This study anticipates at least 100
participants to be recruited and that the inclusion criteria will
provide for a wide range of population groups at each participating
center.
In this study, the MKO Melt for
conscious/moderate sedation will be assessed across a breadth of
medical dentistry indications including oral and maxillofacial
surgery, dental specialties such as periodontics and endodontics,
as well as general dentistry. The participating investigators plan
to administer the MKO Melt to patients under an IRB approved
protocol with informed consent during the patients’ scheduled
dental procedures.
The objective of this study is to evaluate the
MKO Melt for management of pain/discomfort and anxiety during
dental procedures and surgery. We anticipate that the multiple
measures of sedation and satisfaction in this protocol provide a
robust study design and will allow for definitive conclusions to be
drawn.
This study is expected to be completed in the
second or third quarter of 2019.
About Imprimis
Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) is
a commercial-stage pharmaceutical company based in San Diego,
California. In addition to owning the nation’s leading
ophthalmology pharmaceutical compounding business, ImprimisRx, the
Company holds large equity positions in Eton Pharmaceuticals,
Surface Pharmaceuticals and Melt Pharmaceuticals, companies
originally founded as subsidiaries of Imprimis. The Company also
owns royalty rights in certain 505(b)(2) drug candidates being
developed by Eton, Surface and Melt. For more information about
Imprimis, please visit the Investor Relations section of the
corporate website by clicking here.
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc., is a development
stage pharmaceutical company focused on the development and
commercialization of patented non-opioid and non-intravenous (or
non-IV) sedation and anesthesia therapeutics for human medical
procedures in hospital, outpatient, and in-office settings. Melt
intends to seek regulatory approval through the U.S. Food and Drug
Administration’s 505(b)(2) regulatory pathway for these proprietary
technologies. Melt’s core technology is a series of combination
non-opioid sedation drug formulations that may replace or
supplement current sedation modalities for more than 100 million
medical procedures in the United States. Melt is presently a
subsidiary of Imprimis Pharmaceuticals, Inc.
Melt Pharmaceuticals’ vision is to be the
leading provider of non-opioid, non-intravenous conscious sedation
and analgesia pharmaceuticals used for human medical procedures in
hospital, outpatient, and in-office settings.
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.
No Imprimis compounded formulation is
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
Pattonjpatton@imprimispharma.com858-704-4587
Media Contact:Deb
HollidayHolliday Communications,
Inc.deb@hollidaycommunications.net412-877-4519
Source: Imprimis Pharmaceuticals, Inc. and
Melt Pharmaceuticals, Inc.
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