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
NEW YORK--(BUSINESS WIRE)--VR1, Inc. is sharing launch year results, including patient response, of its non-prescription severe headache and migraine nasal spray Ausanil®, 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.
“Many of our patients are often limited in treatment options, and by offering relief within minutes, without concerns of drug-to-drug interactions, or long-term side effects, Ausanil is becoming a preferred solution for many of them”
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 reporting onset of significant relief within the first three minutes of use.1 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 treatment options.
“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.”
Can CGRP Antagonism Help Address Common Migraine Treatment Challenges?
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.2 Recent news reports 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 first-of-a-kind mechanism allows Ausanil’s active ingredient capsicum annuum (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 stomach.”
Treatment Accessibility and Affordability: What Does Ausanil’s Non-Prescription, Homeopathic Classification Mean for Patients?
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.3,4 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).5 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.6 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 affordability.
“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 others nationwide:
“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 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.”
Ausanil Launch Year Update; Potential for Migraine Prevention?
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 from 2014.
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 study to further examine Ausanil’s effectiveness and tolerability for primary headache disorders.
“Many of our patients are often limited in treatment options, and by offering relief within minutes, without concerns of drug-to-drug interactions, or 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 are optimistic the observational study will provide additional support for the intranasal use of capsicum annuum for migraine and severe headache relief.”
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 the FDA.
Visit Ausanil.com to learn more.
About Ausanil®
Non-prescription, homeopathic Ausanil nasal spray is specifically formulated to provide symptomatic rapid relief from severe headache and migraine pain. It is 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 headaches.
Ausanil should not be used for mild or infrequent headaches, atypical migraines, basilar migraines, migraines with abdominal symptoms, or any new onset severe headaches that are unusual for the sufferer. Ausanil should not be used in people with an active nasal infection, active and symptomatic asthma or upper respiratory tract infection, or with a severely deviated nasal septum. Ausanil is not recommended for women who are pregnant or breastfeeding, or for patients under age 18. Individuals allergic to any of the listed ingredients should not 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 by neurologist 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, and 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 are not 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 are 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 are 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, and 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, or 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, and it is not possible for us to predict all of them. We cannot 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 do not 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, 2007.
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