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news.Pozen has submitted the findings from the short-term human volunteer study of the genotoxic potential of Treximet to the FDA.
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The results of this study 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 also 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 85mg, formulated with RT Technology and naproxen sodium 500mg 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.