Healthcare Industry News: RT Technology
News Release - January 15, 2008
POZEN Submits Human Lymphocyte Study for Treximet(TM) (Formerly Known as Trexima(TM))FDA Tentatively Accepts Proposed New Trade Name
CHAPEL HILL, N.C.--(HSMN NewsFeed)--POZEN Inc. (NASDAQ: POZN ) announced today that it has submitted the findings from the short-term human volunteer study of the genotoxic potential of Treximet™ (formerly known as Trexima™) to the U.S. Food and Drug Administration (FDA). The results of this study, the design of which was agreed upon with the FDA prior to its conduct, indicate that no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered to volunteers for seven days. The submission of this study report is in addition to the response made to the FDA in October 2007 which provided clarifying information on the Chinese Hamster Ovary (CHO) assay.
The company has received notification from the FDA that it has tentatively accepted the trade name Treximet (formerly known as Trexima), subject to final NDA Approval, for the proposed product candidate combining sumatriptan 85 mg, formulated with RT Technology™, and naproxen sodium 500 mg in a single tablet.
Treximet, which is currently under review by the FDA for the acute treatment of migraine, is being developed by POZEN under an alliance with GlaxoSmithKline.
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. POZEN’s efforts are focused primarily on the development of pharmaceutical products for the treatment of acute and chronic pain and other pain-related conditions. POZEN has development and commercialization alliances with GlaxoSmithKline for the proposed product candidate Treximet™ which is currently under review by the United States Food and Drug Administration for the acute treatment of migraine, and with AstraZeneca for the proposed product candidate PN 400 for conditions such as osteoarthritis and rheumatoid arthritis in patients who are at risk for developing NSAID-associated gastric ulcers. The company’s common stock is traded on The Nasdaq Stock Market under the symbol “POZN”. For detailed company information, including copies of this and other press releases, see POZEN’s website: www.pozen.com.
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