VR1, Inc. Shares Launch Year Update: First Commercially Available Non-Prescription CGRP Antagonist Ausanil® Emerges As Go-to Solution for Difficult-to-Treat Headache Patient Population | Business Wire
NEW YORK–()–VR1, Inc. is sharing launch year results, including patient response, of
its non-prescription severe headache and migraine nasal spray ,
the first commercially available CGRP (calcitonin gene related peptide)
antagonist that works to rapidly relieve severe headache and migraine
pain without systemic side effects or adverse drug interactions of
commonly used oral or injectable treatments.
Since its launch in March 2014, Ausanil, which is comprised of a
proprietary formulation using capsicum annuum (capsaicin), has helped
thousands of difficult-to-treat migraine and cluster headache patients
nationwide find rapid pain relief, with many
onset of significant relief within the first three minutes of use.<sup>1</sup>
VR1 founder, lifelong migraine sufferer and neurologist Anjan
Chatterjee, MD worked to develop a formulation that effectively balances
the need for rapid pain relief with patient safety and
tolerability—common challenges for the nearly 12 million migraine
sufferers in the U.S. with a sub-optimal response to currently available
“Ausanil was never intended to be a solution for every single person
living with migraines; no one medicine can fill that gap,” said Dr.
Chatterjee. “We developed Ausanil to offer a much needed additional
treatment solution for patients who are crippled by their pain and
unable to function in the midst of their attack for hours or days at a
time. For much of my life, I was that sufferer.”
<b>Can CGRP Antagonism Help Address Common Migraine Treatment Challenges?</b>
In the past decade, there have been major advances in understanding the
therapeutic management of migraines by blocking the release of or
inhibiting the direct source of the headache pain in the brain—a
build-up of CGRP, a pain modulating neurotransmitter in the human
nervous system which is thought to cause the swelling and inflammation
of blood vessels surrounding the brain.<sup>2</sup> Recent focusing on the development of investigational medicines
that rely on capsaicin pathways to block CGRP and therefore, prevent
migraine, are giving millions of patients hope for a new generation of
treatments to become available in several years.
Currently, Ausanil is the only CGRP antagonist commercially available in
the U.S. specifically formulated to treat severe, debilitating
neuro-vascular headaches. This allows Ausanil’s active ingredient <a rel="wpi" target="_blank" title="" href="">capsicum annuum</a>
(capsaicin) to bind directly to receptors on sensory nerves in the nose,
acting as an analgesic by depleting the build-up of CGRP and reducing
the headache pain within minutes.
“Based on intensive, existing clinical research on capsaicin, we
thoughtfully developed Ausanil for intranasal use because it allows the
treatment to work incredibly fast via neural transmission to directly
reduce the headache pain inflammation and thus addresses the biggest
concern for patients—speed of onset of pain relief,” said Chatterjee,
who was involved in the development of CGRP antagonists and antibodies
during his prior roles at Pfizer Inc. and at Merck Research Labs.
“Unlike all other CGRP antagonists and antibodies currently in
development, Ausanil works directly on the nerve to deplete CGRP
build-up—a mode of action that utilizes minute amounts of medicine
locally in the nose—resulting in no meaningful uptake in the
bloodstream. The outcome is a medicine that does not interact with other
medicines or cause side effects in other organs like the heart, liver or
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<b>Treatment Accessibility and Affordability: What Does Ausanil’s
Non-Prescription, Homeopathic Classification Mean for Patients?</b>
Through decades of clinical practice, and as a researcher of
neuroscience medicines, Dr. Chatterjee was well aware of capsaicin’s
role in pain management from its use in ancient Eastern medicine and
homeopathy to existing clinical research (double blind controlled
trials) from the 1990’s onward on its benefits for treatment of
migraines and cluster headaches.<sup>3,4</sup> Understanding the
connection between an old accepted remedy and its current cutting edge
scientific rationale for use (CGRP antagonism), he spent nearly two
years developing the final formulation of Ausanil using capsicum annuum,
an active natural ingredient approved and regulated by the U.S. Food and
Drug Administration. VR1 manufactures Ausanil in the USA at a
FDA-registered facility that meets GMP (good manufacturing practices)
designations required by the FDA.
According to a 2012 survey conducted among 2,500 migraineurs, nearly
half (45.5%) of the patients noted cost as a reason they did not take
commonly used migraine medications such as triptans (e.g., Imitrex,
Relpax, Zomig).<sup>5</sup> Results of a National Institute of Health
study found that 63 percent of patients saved their triptan use for
“bad” migraines due to cost and insurance issues. Alongside high costs,
insurance plans may not approve enough of a medication dosage to
adequately treat some patients symptoms.<sup>6</sup> In 2014, VR1 made
Ausanil available to millions of patients in pain, as a non-prescription
homeopathic treatment retailing at $34.95 (less than 70 cents a dose) to
address two huge patient challenges—treatment accessibility and
“Given capsicum annuum has long been clinically acknowledged as an
effective analgesic for migraines and headaches, the homeopathic
designation allowed us to make Ausanil rapidly available to patients
without the need for a prescription and at an affordable price point. It
is important that patients are able to access multiple viable options.”
said Michele Harris, VR1 Chief of Operations and Marketing.
This unique approach is paying off for thousands of sufferers, and
patients and professionals alike are sharing their experience with many
<i>“I have struggled with migraines for decades and have tried every
migraine product on the market,” said Ausanil user Cheryl Glace. Simply
put, Ausanil is a life changer. My daily life is no longer defined by
whether or not I have a headache.”</i>
<i>“I have recommended Ausanil to dozens of patients,” Bridget Rowan,
RPh, pharmacist and owner of O’Hearns Pharmacy in Cambridge, New York.
It's safe, easy to use, does not require a prescription, no insurance
limits, no drug interactions, convenient, and developed by a
neurologist. It sounded too good to be true! But, as an infrequent
migraine sufferer, I have used the treatment myself and am amazed at the
quick and complete relief. My headache pain is gone in about 4 minutes.
My daughter now uses it and carries it with her. Personally and
professionally, I can say Ausanil is one of my favorites.”</i>
<b>Ausanil Launch Year Update; Potential for Migraine Prevention?</b>
In calendar 2015, the first full year on the market, sales of Ausanil
have gained fast traction and are set to triple the company’s revenue
Available online as well as at hundreds of local pharmacies nationwide,
including Kinney Drugs, VR1 has made it a top priority to educate
thousands of neurologists, family physicians, nurses, pharmacists, as
well as physician assistants and nurse practitioners on the indications
and proper use of Ausanil as an acute treatment. Healthcare teams at the
Mayo Clinic, the University of Southern California, the University of
Kentucky, and others are regularly recommending Ausanil to
difficult-to-treat patients and seeing success.
The Atlantic Neuroscience Institute at Overlook Medical Center in
Summit, New Jersey is currently recruiting patients for a
to further examine Ausanil’s effectiveness and tolerability for primary
“Many of our patients are often limited in treatment options. By
offering relief within minutes, without concerns of drug-to-drug
interactions. Long-term side effects, Ausanil is becoming a preferred
solution for many of them,” said Dr. Seth Stoller, Medical Director of
the Overlook Headache Center and lead study investigator. “We're
optimistic the observational study will provide additional support for
the intranasal use of capsicum annuum for migraine and severe headache
Given existing research suggesting the use of CGRP blockade for migraine
prevention, VR1 is also exploring Ausanil’s potential for future use as
a preventative medication for migraine and pain management. If pursued,
such an indication will likely involve a New Drug Application (NDA) with
to learn more.
Non-prescription, homeopathic Ausanil nasal spray is specifically
formulated to provide symptomatic rapid relief from severe headache and
migraine pain. It's not intended to be a preventative or cure for
migraines or severe headaches.
When used as directed, Ausanil is safe to use several times daily for
migraine and cluster headaches, tension headaches and medication overuse
Ausanil shouldn't be used for mild or infrequent headaches, atypical
migraines, basilar migraines, migraines with abdominal symptoms. Any
new onset severe headaches that are unusual for the sufferer. Ausanil
shouldn't be used in people with an active nasal infection, active and
symptomatic asthma or upper respiratory tract infection. With a
severely deviated nasal septum. Ausanil isn't recommended for women who
are pregnant or breastfeeding. For patients under age 18. Individuals
allergic to any of the listed ingredients shouldn't use Ausanil.
Though non-prescription, it’s important that patients always discuss
using Ausanil and its incorporation into their current treatment
regimens with their doctors.
About VR1, Inc.
VR1 is committed to meeting the needs of patients by providing
therapeutic solutions that are effective, safe and accessible. Founded
and lifelong migraine sufferer Anjan Chatterjee, MD, MPH, MBA, FAAN,
FAHS, FAPA, VR1 is a privately held company that focuses on
providing treatments to address acute pain associated with migraine and
other severe headache conditions.
Forward Looking Statement
This press release contains “forward looking statements” within the
meaning of Section 27A of the Securities Act of 1933 as amended.
Section 21E of the Securities Exchange Act of 1934 and are made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Forward looking statements reflect the current view
about future events. Using the words “plan,” “likely,” “explore,”
“intend,” “set to” and similar expressions as they relate to VR1’s
products identify forward looking statements. Such statements, include,
but aren't limited to, statements relating to our business, products
and services we may offer in the future, sales and marketing strategy
and capital outlook. Forward looking statements are based on our current
expectations and assumptions regarding our business, the economy and
other future conditions. Because forward looking statements relate to
the future, they're subject to inherent uncertainties, risks and
changes in circumstances that are difficult to predict. Our actual
results may differ materially from those contemplated by the forward
looking statements. they're neither statement of historical fact nor
guarantees of assurance of future performance. We caution you therefore
against relying on any of these forward looking statements. Important
factors that could cause actual results to differ materially from those
in the forward looking statements, including a decline in general
economic conditions in the U.S. or globally. Decreased demand for our
products. Market acceptance of our products. The ability to protect our
intellectual property rights. Impact of any litigation or infringement
actions brought against us. Competition from other providers and
products’ risks in product development. Inability to raise capital to
fund continuing operations. Changes in government regulation. The
ability to complete customer transactions and capital raising
transactions. Other factors relating to our industry, our operations
and results of operations and any businesses that may be acquired by us.
Should one or more of these risks or uncertainties materialize.
should the underlying assumptions prove incorrect, actual results may
differ significantly from those anticipated, believed, estimated,
expected, intended or planned.
Factors or events that could cause actual results to differ may emerge
from time to time. It's not possible for us to predict all of them.
We can't guarantee future results, levels of activity, performance or
achievements. Except as required by applicable law, including the
securities laws of the United States, we undertake no obligation to and
don't intend to update any of the forward looking statements to conform
these statements to actual results.
1 Alexianu M., Chatterjee A. “Intranasal capsaicin (IC)
rapidly relieves the pain of migraine and other severe headaches.” 66th
Annual meeting of the American Academy of Neurology. 2014.
2 Bigal ME, Water S, Rapoport, AM. Calcitonin gene related
peptide (CGRP) and migraine. Current understanding and state of
development. Headache. 2013. 53(8):1230-44.
3 Fusco, BM, Barzoi, G, Agro, F. Repeated intranasal
capsaicin applications to treat chronic migraine. British Journal of
Anaesthesia. 2003. 90(6):812.
4 Fusco, BM, Giacovazzo M. Peppers and pain. The promise of
capsaicin. Drugs. 1997 Jun;53(6):909-14.
5 Migraine.com Migraine in America 2012 survey. Available at: http://migraine.com/mia2012/mediaction-cost-issue/.
6 Insurance limitations and cost of triptans negatively
influence use of patterns, quality of life. Medscape. June 18,