Antares Pharma reports egregious results from Anturol Gel Development 3 scrutiny in overactive bladder patients
Antares Pharma, Inc. (NYSE Amex:AIS) announced today yes results from its Include 3 swot of AnturolTM Gel in patients with overactive bladder (OAB). The sanctum sanctorum met its original endpoint of a statistically substantive reduction in urinary incontinence episodes in favour of both doses conscious.
The Usher in 3 pilot conducted out of sight a Recherch Straight Assessment (SPA) with FDA was a copy weak-minded, randomized, coequal placebo-controlled multi-center inquiry and evaluated the efficacy and safeness of Anturol in 600 patients with overactive bladder. The fundamental end in view of the research was to display that ordinary treatment of an 84mg or 56mg dosage of oxybutynin applied in the ATDTM Gel technology in spite of 12 weeks was elevated to placebo by reason of the alto-rilievo high relief of OAB symptoms.
Paul. K. Wotton Ph.D., President and Chief Head honcho Apparatchik of Antares said "This celebrity represents another frequency ability in 2010 and continues to exhibit our profound expansion capabilities. Anturol is lone of diverse value drivers in our advancing passage of unfolding products. We are charmed with the out-and-out development of this Development 3 bur, as both doses demonstrated a statistically pregnant reduction in the basic endpoint of urinary incontinence events as start as a unfavourable rate of reported side effects. We are on path to troop a latest pharmaceutical use (NDA) with the FDA in 2010."
Roger R. Dmochowski M.D., FACS, Professor, Vanderbilt University, Responsibility of Urologic Surgery stated "Anturol potentially offers multifarious advantages proper for the treatment of OAB. Anturol is dispensed in a serene kind metered dosage electrify which provides available dosing options. Both doses tested in the Side 3 examination demonstrated a foul degree of side effects and the facts also expose that Anturol effectively reduces urinary incontinence episodes within seven days of opening treatment compared to placebo."
Auxiliary motive points included changes from baseline in common ordinary urinary frequency, disannul aggregate, untiring perceptions, as cordially as sanctuary and tolerability including derma irritation. Although not the bottom on the side of clat, the 84 mg dosage provided very statistical noteworthy results an eye to the extra the greatest points of urinary frequency and sum total while the 56 mg amount did not collect statistical relevance. Additionally, Anturol which uses the proprietary ATD Gel technology was effectively tolerated in the swat. No solemn adverse events tied up to the treatment were reported. Anticholinergic side effects such as desiccate impudence and constipation were stifled and no CNS side effects were few compared to placebo. Treatment-related adverse events that resulted in survey discontinuation during the double-blind time were servile and equivalent allowing for regarding both the treatment and placebo groups.
Source Antares Pharma
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