FDA Approves Cialis to Treat Enlarged Prostate
"This is potentially the fastest acting of the four," Dr. Wayne Hellstrom, professor of urology at Tulane University School of Medicine in New Orleans, told Reuters. Patients taking Stendra are recommended to take the drug 30 minutes before sexual activity but clinical trials have shown the drug works as fast as 15 minutes. Viagra may take an hour to start working, Reuters reported. In clinical trials, 77 percent of men with general ED were able to get erections after taking Stendra, compared with 54 percent of men taking a placebo pill, WebMD reported. Stendra resulted in successful intercourse for 57 percent of men with general ED, compared with 27 percent of men on placebo. According to the FDA, the most common side effects for men taking Stendra were headache, face redness, nasal congestion, cold-like symptoms, and back pain. In rare cases men may get an erection that does not go away after four hours - a condition known as priapism.
For the original version including any supplementary images or video, visit http://www.cbsnews.com/8301-504763_162-57424144-10391704/fast-acting-erectile-dysfunction-drug-stendra-approved-by-fda/
FDA approves new drug for erectile dysfunction
The new drug is the fifth FDA-approved oral drug for erectile dysfunction. The others are tadalafil (Cialis; Eli Lily), vardenafil (Levitra; Staxyn, Bayer Healthcare Pharmaceuticals), and sildenafil (Viagra; Pfizer). Vivius conducted clinical trials that included more than 1,200 mens sexual health clinic Perth men with erectile dysfunction to evaluate the effectiveness and safety of Stendra at all dosage strengths (50 mg, 100 mg, and 200 mg). Significant improvement in erectile function was observed for all doses in Stendra-treated patients compared to placebo. The pill is taken 30 minutes before engaging in sexual activity. 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, noted Victoria Kusiak, MD, deputy director of the Office of Drug Evaluation III in the FDAs Center for Drug Evaluation and Research.
For the original version including any supplementary images or video, visit http://www.examiner.com/article/fda-approves-new-drug-for-erectile-dysfunction
FDA Approves New Drug for Erectile Dysfunction
Cialis is the first ED drug to be approved for treating benign prostatic hyperplasia (BPH). Commonly known as enlarged prostate, symptoms include difficulty starting to urinate, a weak urine stream, sudden urge to urinate, and frequent urination at night. Eli Lilly's Cialis was approved as an ED treatment in 2003. The new approval is based on clinical trials showing that 5 milligrams of Cialis once a day improve BPH symptoms. "BPH can have a big impact on a patient's quality of life," Scott Monroe, director of the FDA's division of reproductive and urologic products, says in a news release. "A large number of older men have symptoms of BPH. Cialis offers these men another treatment option, particularly those who also have ED, which is also common in older men." Men taking nitrate-based drugs, such as nitroglycerin , should not take Cialis as it can lead to dangerous drops in blood pressure . The FDA also warns men already taking alpha-blockers for BPH not to add Cialis to their treatment regimen. The two types of drug have not been tested together and theoretically could lead to a drop in blood pressure.
For the original version including any supplementary images or video, visit http://men.webmd.com/news/20111006/fda-approves-cialis-to-treat-enlarged-prostate
In clinical trials reviewed by the agency,participants reported statistically significant improvements in erectile function, vaginal penetration and successful intercourse with all three Stendra doses. Todays FDA action marks the first drug approvalforVivus Inc., of Mountain View, Calif., whichlicensed U.S. marketing rightsto avanafil fromMitsubishi Tanabe Pharma Corp. of Japan. Vivus is thebiopharmaceutical companybehind the diet drug Qnexa, whichremains under FDA review. An estimated 30 million U.S. men have some degree of what used to be called impotence. With the arrival of Viagra, the little blue pill destigmatized the condition and gave it a new name: erectile dysfunction, or ED. 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).
For the original version including any supplementary images or video, visit http://abcnews.go.com/blogs/health/2012/04/27/fda-approves-new-drug-for-erectile-dysfunction/