2004 - GelStat to Present Data on New and Effective Migraine Therapy
01/26/04 -- GelStat Corp. (OTC Bulletin Board: GSAC) announced today the upcoming presentation of results from a recently completed clinical trial of its first product, "GelStat(TM) Migraine."
GelStat Migraine is a novel over-the-counter (OTC, non-prescription) medication for acute relief from pain and associated symptoms of migraine and migraine-like headaches.
Data will be presented at "The 17th Annual Practicing Physician's Approach to the Difficult Headache Patient," sponsored by the National Headache Foundation and Finch University of Health Sciences/The Chicago Medical School, held February 10-14 in Rancho Mirage, California.
The presentation, entitled "GelStat Migraine for Acute Treatment of Migraine Pain and Associated Symptoms" will include key findings from a clinical trial in which GelStat Migraine was employed as an early intervention in those with moderate to severe migraine. The study was led by Curtis P. Schreiber, M.D. and Roger K. Cady, M.D., both of ClinVest, the research division of the Headache Care Center in Springfield, Missouri.
(question:only 1 location as testing base?)
Approximately thirty million Americans suffer from migraines and another 20 million from "severe headaches." The economic impact of migraine is substantial, costing the U.S. economy over $22 billion annually, with over $6 billion of that in medication costs, including $2.6 billion spent on OTC headache medications.
Among those with migraine, 57% rely exclusively on OTC medications and well over 90% make use of OTCs as part of their treatment.
Despite this heavy reliance on OTC medications, in only about 25% of those with moderate to severe headache pain do they exhibit any effect, and they are frequently associated with troubling and sometimes serious side effects.
Less than 30% of those with migraine report that they are very satisfied with their usual migraine treatment and two-thirds of those with a prescription for migraine reportedly delay or avoid taking their medications because of concerns over side effects.
GelStat Migraine is administered sublingually (under the tongue) for rapid, effective absorption - avoiding the hour or more delay frequently associated with typical capsules or tablets.
In addition, medications passing through the digestive tract are subject to a "first pass" effect, in which active ingredients may be broken down by stomach acid or destroyed by the liver. Products directly absorbed through blood vessels in the mouth are not subject to this "first pass" effect, and can start working within minutes. GelStat Migraine is provided in single dose (OraDose(TM)) dispensers to ensure ease of use as well as consistent, accurate administration.
The OraDose System includes not only the patent pending dispenser, but also a proprietary, patent pending formulation that is specifically designed to enhance sublingual delivery. Sublingual delivery, though often faster and more efficient than alternate delivery systems, is presently underutilized in the OTC product category.
GelStat Corporation is a healthcare company dedicated to bringing to market advanced OTC healthcare products in a cost-effective manner. A development stage corporation, GelStat became a publicly traded company through a merger with Developed Technology Resource, Inc. on April 30, 2003.
Product development efforts are focused on unmet needs in the OTC consumer healthcare market - areas where GelStat can improve efficacy, safety, and/or convenience. GelStat is dedicated to innovation and committed to building a portfolio of products with significant commercial potential. The Company's initial efforts center on developing products for migraine therapy and to improve sleep, both multi-billion dollar global markets.
For more information, visit www.GelStat.com
Forward-Looking Statements
This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statement other than a statement of historical fact should be considered a forward- looking statement. Such forward-looking statements are based on the Company's current expectations and involve known and unknown risks, uncertainties, or other factors which may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Risks, uncertainties and assumptions include the possibility that the market for the sale of certain products, or all products, may not develop as expected, or at all. Readers are cautioned not to place undue reliance on those forward- looking statements, which speak only as of the date hereof. The company undertakes no obligation and does not intend to release publicly any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect unanticipated events or developments.
Source: GelStat Corporation
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