Patient Study Highlighting Intranasal Capsaicin As An Effective Treatment Option For Rapid Pain Relief Of Severe Headaches And Migraine To Be Presented At 66th Annual American Academy Of Neurology Meeting - KCTV5

Patient Study Highlighting Intranasal Capsaicin As An Effective Treatment Option For Rapid Pain Relief Of Severe Headaches And Migraine To Be Presented At 66th Annual American Academy Of Neurology Meeting

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SOURCE VR1, Inc.

Targeting CGRP, Intranasal Capsaicin Shows Potential in Offering Rapid Pain Relief to Numerous Sufferers in Need of Additional Treatment Options

NEW YORK, April 30, 2014 /PRNewswire/ -- Real-world patient case series analysis supporting the use of intranasal capsaicin as an effective rapid treatment for severe headache and migraine pain will be presented at the 66th American Academy of Neurology (AAN) Annual Meeting in Philadelphia, PA on Thursday, May 1, 2014 during Poster Session VII.

Intranasal administration of extracts of capsicum annuum such as capsaicin work locally in the nose by desensitizing the trigeminal nerve, resulting in the reduction of CGRP, the neurotransmitter responsible for migraine pain.

Intranasal capsaicin has been shown in multiple research studies to have efficacy in the treatment of migraines and cluster headaches and is thought to work by the calcium-mediated desensitization of the trigeminal nerve and resultant depletion of calcitonin gene-related peptide or CGRP, the neurotransmitter responsible for migraine pain.1,2,3,4 Until now, intranasal capsaicin has not been evaluated in other types of severe headaches, and its effectiveness in these patients was not known. Also, it is not well understood how tolerable it is in patients, and how quickly patients typically obtain headache relief.

Neurologists Dr. Maria Alexianu MD PhD and Dr. Anjan Chatterjee MD MPH are now reporting on an extended case series of 18 adult patients (ages 28-65) with different severe headache diagnoses (cluster headache, post-traumatic headache, tension type headache and medication overuse/rebound headache) in addition to migraine headaches, examining intranasal capsaicin to treat their headaches. All eighteen patients had moderate to severe functional disability as a result of the severity of their headaches and expressed dissatisfaction with their treatment regimen that included several different commonly used prescription and non-prescription medications for headaches, including naproxen, sumatriptan, rizatriptan, verapamil, butalbital and others.

Patients were asked to use intranasal capsaicin to treat their headaches without the use of any additional medication and report on the effectiveness and tolerability of the medication and whether they would continue to use it for future headache episodes. Analysis reported on the treatment of index episodes with intranasal capsaicin and found that over 72 percent of patients (13) experienced complete pain relief, as reported on a five-point scale from no relief (1+) to complete pain relief (5+). Most remaining patients also reported experiencing some pain relief [4+ (1 patient); 3+ (2 patients) and 2+ (1 patient)] and one patient reported no pain relief (1+).

Eight patients (44.4%) reported immediate pain relief (<1 minute after use), 7 (38.9%) had intermediate onset of pain relief (between 1 to 3 minutes after use), 2 (11.1%) had "delayed" relief (> 3 minutes after use) and one (5.6%) had no response to the medicine. Reported relief duration ranged from 30 minutes up to several hours. All 18 patients reported experiencing the local adverse event of the nasal sting, lasting between two to 10 minutes, and lacrimation (tearing of the eyes). All 17 patients who achieved pain relief continued to use intranasal capsaicin for subsequent episodes and reported that the sting would not dissuade them from using the medication.

"Extracts of the chili pepper plant (capsicum annuum) such as capsaicin and congeners have long been known for their pain relieving properties, and it is important we continue to take a closer look at a principle that has shown to be effective in treating headaches and migraines, specifically through intranasal administration," said Dr. Chatterjee, neurologist and founder of VR1, Inc. "By depleting CGRP, intranasal capsaicin is able to specifically target the source of the headache pain. These results emphasize the potential that intranasal capsaicin may offer in terms of rapid pain relief to severe headache and migraine sufferers who are in need of new treatment options."

The results analysis will be shared by Dr. Alexianu and Dr. Chatterjee on Thursday, May 1, between 5 and 6:30 p.m., under poster presentation P7.179 at the AAN meeting.

About Capsaicin
Capsaicin is a constituent of oleoresin capsicum, which is an extract of the chili pepper plant capsicum annuum. Extracts of the plant, including capsaicin, have for centuries been used as an analgesic and more recently, studied in the treatment of severe nerve pain in conditions such as post shingles pain and diabetic neuropathy. In the last two decades, clinical data has demonstrated that nasal administration of capsicum annuum or its components like capsaicin have successfully treated pain associated specifically with cluster headaches and migraine.1,2

Intranasal administration of extracts of capsicum annuum are thought to work locally in the nose by desensitizing the trigeminal nerve, resulting in the reduction of CGRP molecules. CGRP is thought to cause the swelling and inflammation of blood vessels surrounding the brain, which is associated with the pain of severe headaches and migraine. When administered locally in the nose, extracts of capsicum annuum will cause a stinging sensation that indicates the action on the sensory nerve has taken place.1,2,3,4

About Migraine – An Unmet Need
Migraine ranks in the top 10 of the world's most disabling medical conditions with nearly 36 million sufferers in the U.S. alone, including people of all ages. More than 90 percent of sufferers are unable to work or function normally during their migraine attacks. Direct medical costs and indirect costs of migraine, including millions of missed work days and lost productivity, can run up to approximately $29 billion a year in the U.S.

Many treatments for severe headaches and migraine have limitations due to a variety of factors, including: onset of effect (some medications require up to an hour or more to achieve significant effect), side effects (such as gastrointestinal ulcers, liver damage and risk of dependence), and potential adverse interactions with other medications, including antidepressants and blood thinners. Certain treatments may also be contraindicated for those with heart disease or a family history of heart disease or diabetes.

American Headache Society guidelines generally advise against using prescription therapies, specifically opioids, as first-line treatment for migraine due to risk of dependency. The guidelines also warn that commonly used over-the-counter (OTC) pain relievers should not be used more than twice weekly due to an increase in "medication overuse headache" as well as potential liver, kidney and stomach issues.

About Dr. Anjan Chatterjee
Board certified in Neurology and Psychiatry, Dr. Chatterjee has more than two decades of direct patient care experience, treating patients with a wide variety of neurological and psychiatric disorders. Over the last decade, Dr. Chatterjee has worked at Merck Research Labs and Pfizer to develop neuroscience medicines. Recently, Dr. Chatterjee founded VR1 Inc. VR1 focuses on providing treatments to address acute pain associated with migraine and other severe headache conditions.

Dr. Chatterjee has presented peer reviewed research at multiple medical conferences in the U.S. and Europe and has authored multiple research manuscripts published in peer reviewed medical journals, including Movement Disorders, Headache, Cephalalgia, Journal of Neurology Neurosurgery and Psychiatry, Biological Psychiatry, Journal of Clinical Psychopharmacology and the American Journal of Psychiatry. He is also a reviewer for several peer reviewed medical journals, including Neurobiology of Disease, Journal of Neurology Neurosurgery and Psychiatry, Psychiatry Research and Movement Disorders. He is a member of several professional organizations, including the American Academy of Neurology (AAN), American Headache Society (AHS), Movement Disorders Society (MDS), American Psychiatric Association (APA), American Medical Association (AMA) and American Association of Family Practice Physicians (AAFP). Dr. Chatterjee graduated Medical School from the University of Delhi, India; earned a Master's in Public Health (Epidemiology and Biostatistics) from Columbia University, and has a Master of Business Administration from Columbia Business School.

About VR1, Inc.  
VR1 is committed to meeting the needs of patients by providing therapeutic solutions that are effective, safe and accessible. VR1 focuses on providing treatments to address acute pain associated with migraine and other severe headache conditions.

www.ausanil.com

References:

1 Fusco, BM, Giacovazzo M. Peppers and pain. The promise of capsaicin. Drugs. 1997 Jun;53(6):909-14.

2 Fusco, BM, Barzoi, G, Agro, F. Repeated intranasal capsaicin applications to treat chronic migraine. British Journal of Anaesthesia.  2003. 90(6):812.

3 Liu L, Oortgiesen M, Li L, Simon SA. Capsaicin inhibits activation of Voltage Gated Sodium Currents in Capsaicin-sensitive Trigeminal Ganglion Neurons. Journal of Neurophysiology. 2001. 85;745-758.

4 Meents, JE, Neeb L, Reuter U. TRPV1 in Migraine Pathophysiology. TINS. 2010. Vol 16: 153-159.

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