The US Food and Drug Administration approved Friday a new drug to treat erectile dysfunction. Stendra, from Vivus Inc. is the newest drug in a line of phosphodiesterase type 5 (PDE5) inhibitors, which include drugs like Viagra and Levitra. These drugs boost blood flow to the penis, reported the Wall Street Journal, and help men to sustain erection - a common problem in older men. This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs, said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research, reported WebMd. Stendra, the brand name for avanafil, is taken in 50, 100 or 200 milligram doses 30 minutes before sexual activity. Researchers have said that Stendra worked as early as 15 minutes after taking it in some patients, which would make it work twice as fast as competitor Viagra, said ABC News. The side effects of Stendra are shared by similar drugs and include headache, flushing and back pain - along with the possibility of an erection that lasts far longer than usual. … Continue reading →

Stendra Works Like Cialis, Levitra, Staxyn, Viagra April 27, 2012 -- The FDA has approved Stendra (avanafil) for men with erectile dysfunction (ED). Stendra, from Vivus Inc., is in the same drug class as the four oral ED drugs now on the U.S. market: Cialis, Levitra, Staxyn (an orally dissolving version of Levitra), and Viagra. An estimated 30 million U.S. men have ED, according to the FDA. "This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, states in a news release. In some participants in clinical trials, the drug was effective in as little as 15 minutes. Some men in clinical trials reported improved erections more than six hours after taking the drug. In clinical trials, 77% of men with general ED were able to get erections after taking Stendra, compared to 54% of men taking an inactive placebo pill. Among men with diabetes-related ED, 63% were able to get erections after taking the drug, compared to 42% of … Continue reading →

MOUNTAIN VIEW, Calif., April 27, 2012 /PRNewswire/ -- VIVUS, Inc. (VVUS) today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S. "Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED," said Peter Tam, president, VIVUS. "We believe that the PDE5 selectivity and absorption profileof STENDRA make it an important new treatment option for many men with erectile dysfunction." More than 1,200 men with ED participated in clinical studies evaluating the efficacy and safety of STENDRA. STENDRA at all doses tested (50mg, 100mg and 200mg) met all primary efficacy endpoints. Significant improvement in erectile function was observed for all doses in STENDRA-treated patients compared to placebo. It is recommendedthat STENDRA should be taken approximately 30 minutes before sexual activity. STENDRA should not be taken more than once per day. For more information about STENDRA, please visit http://www.Stendra.com. "STENDRA is the first of a new generation of PDE5 inhibitors, and the approval marks an exciting new milestone for the millions … Continue reading →

A medication that could be a faster-working alternative to Viagra and other erectile dysfunction drugs got approval from the Food and Drug Administration Friday. The brand name you will be hearing in those inevitable ads: Stendra. It's made by a company called Vivus, Inc., and belongs to the same class of medicines as Viagra, from Pfizer Inc., Cialis, from Eli Lilly, and Levitra, from GlaxoSmithKline and Bayer. All inhibit the same enzyme, PDE5, and work by increasing blood flow to the penis. About 30 million men have erectile dysfunction -- trouble getting or keeping an erection -- the FDA says. The approval "expands the available treatment options" for such men and "enables patients, in consultation with their doctor, to choose the most appropriate treatment," FDA official Victoria Kusiak said in a statement. The statement says patients will be instructed to take Stendra 30 minutes before sexual activity. But, in studies, the drug has been shown to work in as little as 15 minutes, which is faster than the 30 to 60 minutes reported for other drugs (though they have not been directly compared in studies). The new drug will come with the same warnings as the others: 2% of patients … Continue reading →

The U.S. Food and Drug Administration approved a new erectile dysfunction drug, Stendra, on Friday. The pill's makers claim it works faster than Viagra. (EPA/ANTONIO LACERDA / April 27, 2012) April 27, 2012, 11:45 a.m. The U.S. Food and Drug Administrationapproved Stendra, a new drug to treat erectile dysfunction in men, on Friday. Like Viagra, Cialis and Levitra, Stendra (generic name avanafil) is a pill, and is in a class of drugs called PDE5 inhibitors.These work by increasing blood flow to the penis. Patientscan take Stendra as needed 30 minutes before sexual activity, the FDA said in a statement released Friday. One possible advantage of the new drug? Vivus Inc., the company that markets Stendra, has claimed that it will provide erections in 15 minutes or less in about half as much time as Viagra can. Like other PDE5 inhibitors, Stendra is not recommended for men who take nitrates for chest pain, because taking both drugs can cause a rapid drop in blood pressure, the FDA said.Side effects reported during clinical trials of Stendra included headache and cold-like symptoms. The National Kidney and Urologic Diseases Information Clearinghouse provides information about erectile dysfunction and its treatment at this website. See original … Continue reading →

MOUNTAIN VIEW, Calif., April 28 (UPI) -- The U.S. Food and Drug Administration has approved Stendra, or avanafil, tablets for the treatment of erectile dysfunction in men, officials said. Peter Tam, president of the biopharmaceutical company Vivus, said the approval is the first for nearly a decade to help treat the 30 million U.S. men with erectile dysfunction. "Patients and treating physicians continue to report significant dissatisfaction with current treatments of erectile dysfunction," Tam said in a statement. "We believe that the PDE5 selectivity and absorption profile of Stendra make it an important new treatment option for many men with erectile dysfunction." More than 1,200 men with erectile dysfunction participated in clinical studies evaluating the efficacy and safety of Stendra, and significant improvement in erectile function was observed for all doses -- in 50milligrams, 100mg and 200mg -- compared to placebo. It is recommended that Stendra should be taken approximately 30 minutes before sexual activity and should not be taken more than once per day. Erectile dysfunction affects an estimated 52 percent of men between the ages of 40 and 70, Tam said. Read the original here: New drug approved for erectile dysfunction … Continue reading →