Dallas, Texas 02/14/2014 (FINANCIALSTRENDS) – The $693 million market capped drug maker VIVUS, Inc. (NASDAQ:VVUS) announced in the last week of February that the regulator U.S. Food and Drug Administration has acceded to its request and given its in principal approval to file a follow up add on application which adds clinical data to its previously submitted application seeking approval for its drug candidate “STENDRA(TM) (avanafil).” The new data contains updated “efficacy and safety” information which has been collected from its ongoing “study TA-501” which had been published under the header “A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction” previously. The due date for additional filing on this application is late September 2014.
It is appropriate to note here that VIVUS, Inc. (NASDAQ:VVUS) had in the past disclosed positive outcomes from its multi centre study whose end result was to determine the efficacy and the safety parameters to be followed if the target drug “STENDRA” had to be administered in two doses separated by 15 minutes. The study involved 440 patients being enrolled in study centres across 30 locations across U.S. The results showed that the patients who had been administered the target drug were showing substantially improved recovery when compared against the treatment rates of existing lotions in obtaining erections. The USP of the target drug is that it is found to be effective to cause erection with the application of the balm just 10 minutes with a 200 mg dose, where as it took 12 minutes for the erection to be caused for a 100 mg dose. Other drugs in the market today have a prescribed time limit of 30 minutes before intercourse application for them to be effective. On the back of this update, the stock was up 6 percent during trading this week.