The 104 trial was an 8-week, double-blind, randomized, cross-over study, in which 131 hypertensive volunteers between 50 and 75 years of age were enrolled to receive either naproxcinod 750 mg bid for 2 weeks, followed by naproxen 500 mg bid for 2 weeks, or these compounds in the reverse order. Subjects received a 2-week placebo wash-out at the beginning of the study and between the active treatment periods. Eligible subjects were not current Non-Steroidal Anti-Inflammatory Drug (NSAID) users, had controlled hypertension, and could receive stable doses of up to 2 different classes of antihypertensive drugs.
NicOx is developing naproxcinod in late phase 3 clinical studies, which are designed to demonstrate that it is safe, well tolerated and effective for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to traditional NSAIDs and COX-2 inhibitors. The results of the third phase 3 trial for naproxcinod (the 303 study) are expected before the end of the year and the filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) a product-driven biopharmaceutical company dedicated to the development and future commercialization of investigational drugs for unmet medical needs. NicOx is applying its proprietary nitric oxide-donating technology to develop an internal portfolio of New Chemical Entities (NCEs) in the therapeutic areas of inflammatory and cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a proprietary
NCE and the first compound in the Cyclooxygenase-Inhibiting N
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