April 22, 2015, Summit, NJ – The Headache Center at Overlook Medical Center and Atlantic Neuroscience Institute has started recruiting patients for an observational study to assess the safety and tolerability of non-prescription, homeopathic severe headache and migraine nasal spray Ausanil® in the treatment of primary headache disorders, including migraine, cluster headache and severe tension headaches. The study will also examine several secondary outcomes: headache pain, functional outcome, time loss to headache and overall patient satisfaction.
“In clinical practice in pain management and neurology, we continuously see patients who are in need of effective headache treatment that provides rapid onset of relief without concern of potential long-term side effects or adverse drug interactions,” said Maria Alexianu, M.D., PhD, one of the study’s lead investigators at Overlook Medical Center. “In helping patients manage their treatment plan, we continuously work to offer viable new treatment options that are safe and effective. We are optimistic this study will provide additional support for the intranasal use of capsicum annuum for migraine and severe headache relief.”
For several decades, research has demonstrated that nasal administration of extracts from the oleoresin capsicum plant (chili pepper plant) such as capsaicin have successfully treated migraines and cluster headaches. Acting locally in the nose, Ausanil is thought to work by the calcium-mediated desensitization of the trigeminal nerve and resultant depletion of calcitonin gene-related peptides (CGRP), the “pain” neurotransmitters responsible for migraine pain. Reduction in the release of CGRP leads to a reduction in the swelling and inflammation of blood vessels that surround the brain—resulting in pain relief.
“For more than a year, Ausanil has been available to patients as a non-prescription treatment option for rapid relief of severe headaches and migraines, and we continue to receive positive feedback from users—many of whom have tried numerous medications, prescription and over-the-counter, to unsuccessfully alleviate their pain quickly and safely,” said Michele Harris, director of operations and marketing at VR1, Inc. “We recognize the treatment challenges millions of headache sufferers face, and aim to continue closely examining how Ausanil may meet their needs through clinical trials.”
Currently, Overlook Medical Center is recruiting patients for the study who are between 18–80 years of age, are being treated by a physician for primary headache disorder, have not used capsicum annuum as a headache treatment, and are willing to document their headache response. If you are interested in enrolling in this clinical trial, please contact Seth Stoller, MD at 908-522-2709 or via email.
To learn more about this observational study (ClinicalTrials.gov Identifier: NCT02392273), visit the Atlantic Center for Research website.
Ausanil was developed as a non-prescription homeopathic nasal spray treatment to provide rapid relief from severe headache and migraine pain. When used in accordance with directions, Ausanil is safe to use several times daily without systemic side effects or adverse drug interactions. Ausanil may also be an effective treatment option for cluster headaches, chronic daily headaches, frequent tension headaches and medication overuse headaches.
Specifically formulated for severe headaches and migraines, Ausanil should not be used for mild or infrequent headaches, sinus headaches, atypical migraines, basilar migraines, migraines with abdominal symptoms, or any new onset severe headaches that are unusual for the sufferer. New onset headaches that are severe and come on suddenly require immediate medical attention. 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. People allergic to any of the listed ingredients should not use Ausanil.
While Ausanil is available without a prescription, it’s important that patients always discuss using Ausanil and its incorporation into their current treatment regimens with their doctors.
About Migraine – An Unmet Need
Migraine ranks in the top 10 of the world's most disabling medical conditions with more than 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 firstline 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 Overlook Medical Center
Overlook Medical Center, located in Summit, NJ, is part of Atlantic Health System, one of the largest non-profit health care systems in New Jersey that includes Chilton Medical Center, Goryeb Children’s Hospital, Morristown Medical Center, and Newton Medical Center. Accredited by The Joint Commission, Overlook Medical Center is recognized by U.S. News & World Report as a “Best Regional Hospital” for Neurology & Neurosurgery, Gastroenterology & GI Surgery, Geriatrics, and Urology. Overlook Medical Center is certified as a Level IV Epilepsy Center and home to the Brain Tumor Center of New Jersey with the largest team of neuroscience specialists in New Jersey.