Vivus Announces FDA Approval Of STENDRA? (avanafil) Tablets For The Treatment Of Erectile Dysfunction
This action causes increased blood flow into the penis leading to an home page erection. Notably, PDE5 inhibitors affect the penis only in the presence of sexual stimulation. Sildenafil was the first PDE5 inhibitor approved by the FDA for treatment of ED in 1998. The FDA-approved prescribing information for sildenafil indicates a typical dose is 50 mg to be taken approximately one hour before intended sexual activity. Sildenafil is also available in 25 mg and 100 mg tablets to permit dosage adjustment based on individual response, as prescribed by your doctor. Sildenafil is intended for use as needed. The AUA reports the effects of sildenafil can last from one-half hour up to four hours. Taking sildenafil with a full meal can delay the onset of drug activity. Tadalafil Tadalafil is a PDE5 inhibitor, which acts to improve the capacity to achieve and maintain an erection by the same mechanism as does sildenafil. The FDA approved this medication in 2003 for use on an as-needed basis.
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Food and Drug Administration. On Friday the FDA approved Vivus Inc.'s Stendra to take as an "as-needed" pill for men before sexual activity. New "Viagra condoms:" Do they really work? More than 30 million men in the U.S. are affected by erectile dysfunction (ED). Current ED drugs on the market include Pfizer Inc.'s Viagra, Eli Lilly's Cialis and GlaxoSmithKline and Bayer's drug Levitra. The new drug Stendra, the brand name for avanafil, is the first new erectile dysfunction drug in a decade for this class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. "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," Dr. Victoria Kusiak, deputy director of the Office of Drug Evaluation III in the FDA's Center for Drug Evaluation and Research, said in an FDA statement .
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FDA Approves New Erectile Dysfunction Drug Stendra
For the last half of the 20th century, it has been used as a sedative, and since 1967 as a treatment for Parkinson's disease. In men suffering from erectile dysfunction, the drug stimulates brain centers involved in sexual response and activates spinal nerves to increase blood flow to erectile tissue. TAP Pharmaceuticals, a joint venture between Abbott Laboratories of Abbott Park, Ill., and Japan's Takeda Chemical Industries, said it decided to withdraw the application for Uprima so it can complete several ongoing studies to confirm the drug's safety and effectiveness. The FDA nod initially was expected in July based on advice from a FDA expert advisory committee, which in April voted 9-3 to recommend that agency officials proceed with its approval. The FDA committee supported approval of Uprima despite the potential for serious side effects when it is taken with nitrates, a common drug for heart disease, and its apparent interaction with alcohol, which could lead to dangerously low blood pressure, a slow heart rate, and fainting. Viagra also can cause adverse reactions when taken with nitrates. The committee also voted for approval despite questions regarding the overall effectiveness of Uprima. These questions center on whether the clinical trials of the drug truly included men with severe sexual dysfunction.
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Fast-acting erectile dysfunction drug Stendra approved by FDA
Visit www.fda.gov/medwatch , or call 1-800-FDA-1088. About VIVUS VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. Vivus resubmitted the Qnexa NDA in October 2011, which has a FDA action date of July 17, 2012. On February 22, 2012, in a 20-to-2 vote, the U.S.
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Drugmaker Pulls Impotence Drug out of FDA Approval Process
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 Dr. Victor Kusiak, a deputy director within the FDAs Center for Drug Evaluation and Research. Stendra is the newest of the phosphodiesterase type 5 (PDE5) inhibitors,which include Viagra (sildenafil), Levitra (vardenafil) and Cialis (tadalafil). All boost blood flow to the penis to help men achieve and sustain an erection. However, Stendra tablets, to be taken 30 minutes before sexual activity,go to work in as little as 15 minutes, according to clinical trial results submitted to the FDA. Quick onset of action is important to men,Dr. Ira Sharlip, a urology professor at UC San Francisco, and former president of the International Society for Sexual Medicine , told ABCNews.com. In an interview Thursday, on the eve of the FDA decision, Sharlipsaid Stendra likely wouldappeal more to ED sufferers whose opportunities for sexual activity are more casual, than to thosewho have sex on a more predictable basis. Clinical trial resultswith more than 1,200 men indicated that Stendra alsoclears the body more quickly than the other ED drugs in the same class, according to data submitted to the FDA. In a Phase II study, Stendraworked as well as Viagrawhile producing less low blood pressure in cardiac patients who take nitroglycerin . In the two Phase III trials that compared Stendrawith a placebo, there were no reports of blue vision or prolonged, painful erections (priapism),which are infrequent side effects associated with Viagra.In rare cases, men taking any of the PDE5 drugs have reported sudden decreases in hearing or loss of hearing.
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FDA Approves New Drug for Erectile Dysfunction
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 men taking placebo. Stendra resulted in successful intercourse for 57% of men with general ED (vs. 27% of men taking placebo) and for 40% of men with diabetes-related ED (vs.
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