PHARMADRUG
FILES FOR FDA
ORPHAN DRUG DESIGNATION FOR DMT
IN
STROKE
Toronto,
Ontario--(Newsfile Corp. - February 11,
2021) -
PharmaDrug Inc. (CSE: BUZZ) (OTC: LMLLF) ("PharmaDrug"
or the "Company"),
a specialty pharmaceutical company focused on the research,
development and commercialization of
controlled-substances, natural medicines such
as
psychedelics, cannabis and naturally-derived approved
drugs, is
pleased to announce it has filed an application with the U.S. Food
and Drug Administration ("FDA") to receive Orphan Drug Designation
("ODD") for N,N-Dimethyltryptamine ("DMT") in the treatment
of acute ischemic stroke patients presenting for
emergency medical assistance within
3-hours of
symptom onset.
Acute ischemic
stroke is characterized by the sudden loss of blood circulation to
an area of the brain, resulting in a corresponding loss of
neurologic function. Around 85% of all strokes are due to a
blockage cutting off the blood supply to the brain.
Stroke-related
costs in the United States were approximately $46 billion between 2014 and 2015.
(Source:
CDC)
In pre-clinical
research, DMT has been shown to improve ischemic brain injury in rats,
both by decreasing brain lesion volume and by improving subsequent motor
function recovery. Following acute ischemic stroke DMT
activates the sigma-1 receptor (Sig-1R) and critical downstream
pathways known to enhance production of anti-stress and antioxidant
proteins; the impact of which, specifically
diminishes the deleterious
impact
of hypoxia
and oxidative stress to brain
cells.
Restoration of blood flow to affected regions of the brain through
administration of tissue plasminogen activator (tPA aka alteplase), long considered
gold-standard treatment for ischemic stroke, often only partially
rescues damaged brain regions. As such, the development of novel
approaches to treat ischemic stroke, such as PharmaDrug's DMT
program, represent a critical development in reducing patients
resulting neurological deficit.
"We are
building an
industry-leading foundation to explore the clinical potential of DMT in rare
neuropsychiatric and neurological disorders. With the submission of our
orphan drug application to the FDA now complete we will move
swiftly to
accelerate the research and development of DMT for acute ischemic
stroke," said Daniel Cohen, CEO of PharmaDrug.
"Additionally,
we will
continue to broaden our DMT clinical programs
by taking
advantage of
valuable FDA regulatory incentives such as
orphan drug, fast track and breakthrough therapy
designations."
The Company's
psychedelic pharmaceutical strategy will focus on DMT by expanding
its product pipeline through licensing, pre-clinical and clinical
research, forming research collaborations
with academic institutions and industry, broadening its
intellectual property portfolio with unique formulations,
development
of novel
uses and delivery systems, and by adding medical and clinical
experts to its scientific advisory board.
The Orphan Drug Act
grants special status to a drug or biological product to treat a
rare disease or condition upon request of a sponsor. This status is
referred to as orphan designation (or sometimes "orphan status").
The FDA grants ODD status to products that treat rare diseases,
providing incentives to sponsors developing drugs or biologics. The
FDA defines rare diseases as those affecting fewer than 200,000
people in the United States at any given time. ODD would qualify
DMT for certain benefits and incentives, including seven years of
marketing exclusivity if regulatory approval is ultimately received
for the designated indication, potential tax credits for certain
clinical drug testing costs, activities, eligibility for orphan
drug grants, and the waiver of the FDA New Drug Application filing
fee of approximately USD $2,400,000.
About
PharmaDrug Inc.
PharmaDrug is a
specialty pharmaceutical company focused on the research,
development and commercialization of controlled-substances and
natural medicines such as psychedelics, cannabis and
naturally-derived
approved
drugs. The Company owns 80% of Pharmadrug Production GmbH, a German medical cannabis
distributor, with a Schedule I European Union narcotics license and
German EuGMP certification allowing for the
importation and distribution of medical cannabis to pharmacies in
Germany and throughout the EU. The Company also owns 100% of Super
Smart, a Dutch company building a modern adult use psychedelic
retail business with an elevated and educational focus. PharmaDrug
recently acquired Sairiyo Therapeutics, a biotech company that
specializes in researching and reformulating established natural
medicines with a goal of bringing them through regulatory and
research driven clinical trials.
For further
information, please contact:
Daniel Cohen, Chairman and
CEO
dcohen@pharmadrug.co
(647) 202-1824
Caution Regarding
Forward-Looking Information:
THE CANADIAN SECURITIES
EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE
ADEQUACY OR ACCURACY OF THIS RELEASE.
This news
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based on current expectations. These statements should not be read
as guarantees of future performance or results of the Company. Such
statements involve known and unknown risks, uncertainties and other
factors that may cause actual results, performance or achievements
to be materially different from those implied by such statements.
Although such statements are based on management's reasonable
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of 1933, as amended (the "U.S. Securities Act"), or applicable
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risk factors which could cause the Company's actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking information contained herein, such as, but not
limited to dependence on obtaining regulatory approvals; the
ability to locate additional supply of medical cannabis, owning
interests in companies or projects that are engaged in activities
currently considered illegal under United States federal law;
changes in laws; limited operating history, reliance on management,
requirements for additional financing, competition, hindering
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