Ramifications Of Stendra's FDA Approved Label Extension

Great News to Investors and Patients, But What is Vivus's Ultimate Destiny

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Source: Vivus

Corporate Development. On September 18, 2014, the United States Food and Drug Administration (US FDA) approved Vivus, Inc.'s (NASDAQ: VVUS) label extension for Stendra (Avanafil) – the company's lead drug to treat erectile dysfunction (ED). The Agency's approval of Avanafil was based result of Vivus's Phase 3 clinical trial "TA-501" – A randomized, double-blind, and placebo controlled in 440 patients at various sites in the U.S.

Under new labeling, Stendra can be taken – with or without food –within 15 minutes before sexual activity. No other competitor has such a fast onset of action. Available in multiple dosage strength (50, 100 and 200 mg tablets), Avanafil is indicated for men afflicted by ED who are at least 18 years of age. According to Vivus's press release, Stendra can also be taken with up to three drinks of alcohol. However, that does not mean patients should consume alcohol with the medicine, as alcohol is detrimental the patient's overall health.

Read More at: Retail Investor 360

Disclosure: We are neither long nor short USEC. Stocks under $100 million market cap are high-risk investments. Nevertheless, extensive due diligence will reduce such risks. 

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