Dallas, Texas 01/31/2014 (FINANCIALSTRENDS) – The $778 million market capped drug maker VIVUS, Inc. (NASDAQ:VVUS) in association with its development partner Auxilium Pharmaceuticals, Inc. (AUXL) announced earlier last week that their supplementary new drug application have been accepted by the U.S. Food and Drug Administration on 23rd January. The drug firm had sought the approval of the regulators on providing supplementary improvements to the approved drug STENDRA™ (avanafil).
This supplemented target drug was formulated and its efficacy and safety data was confirmed from their study called “A Randomized, Double-Blind, Placebo-Controlled Evaluation of Avanafil for On-Demand Treatment of Men with Erectile Dysfunction.” The review date for the supplemental filing has been scheduled for 20th September.
It is appropriate to note here that VIVUS, Inc. (NASDAQ:VVUS) had 2013 announced that it had gathered positive results from its clinical trials designed to test the efficacy of the supplemented drug 15 minutes post administration of two doses of the target drug STENDRA™. This initial trial involved administering of STENDRA™ to 440-patients who had enrolled in the study across 30 sites in the U.S.
In spite of the positive updates share price of VIVUS, Inc. (NASDAQ:VVUS) has been struggling to show appreciation at the markets. It has slid down by a big 16.48 percent during trading in the past one week.
STENDRA (avanafil) is an approved drug by the U.S. Food and Drug Administration. It is widely prescribed by physicians from across the globe to treat erectile dysfunction in men. The drug is administered in the form of a external cream and is to me administered 30 minutes before sexual activity. VIVUS, Inc. (NASDAQ:VVUS) partner Auxilium Pharmaceuticals, Inc. (AUXL) holds the exclusive licenses to market STENDRA across U.S. and Canada. The successful approval of the supplementary drug application filed by the two firms is expected to add to the potential of the drug across the globe.