On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) approved the drug Stendra (avanafil), a drug used to treat erectile dysfunction (“ED”). Marketed by Vivus, Inc., Stendra is intended to be taken by men on an as-needed basis approximately thirty minutes prior to sexual activity. While several drugs used to treat ED are already on the market, including Viagra (sildenafil citrate) and Cialis (tadalafil), this recent approval marks the expansion of treatment options for those with ED.
Under the FDA’s regulatory regime, drug sponsors must demonstrate that a drug is safe and effective for its intended use in order to support a New Drug Application (“NDA”). According to the FDA, the safety and effectiveness of Stendra was demonstrated through three double-blind, placebo-controlled studies. While there is no one standard for how safety and effectiveness may be demonstrated, the FDA often requires drug sponsors to perform animal studies and/or human clinical trials to ensure that the benefits of such drugs outweigh the risks. More information about the NDA process may be accessed here.