FDA approval for stendra erectile dysfunction

Source: stendra, a new drug for erectile dysfunction, was approved by the food and Drug Administration of the United States on April 28, 2012 Erectile dysfunction refers to the inability of men to erect or maintain erectile difficulties An estimated 300000 men in the United States are affected by erectile dysfunction Stendra is an oral preparation that can be taken 30 minutes before a patient's sexual activity as needed Doctors should follow the minimum dose prescribed by stendra "This approval expands the options available to treat erectile dysfunction in men, allowing patients to choose the most appropriate treatment they need by consulting a doctor." , said Victoria Kusiak, MD, deputy director of the third office of drug evaluation, FDA drug evaluation and research center Stendra is a phosphodiesterase 5 (PDE5) inhibitor that helps increase penile blood flow As with other PDE5 inhibitors, stendra cannot be taken with nitrates for chest pain (angina) because it may cause a sudden drop in blood pressure PDE5 inhibitors rarely cause color changes It has been reported that the vision of single or double eyes of individual men suddenly lost after taking PDE5 inhibitor Sudden hearing loss or loss has also been reported in patients taking PDE5 inhibitors Patients with sudden loss of vision or hearing who take PDE5 inhibitors should immediately stop taking PDE5 inhibitors, including stendra, and call a doctor immediately Stendra clinical studies report that the most common side effects greater than 2% include headache, facial redness and other areas (Flushing), nasal congestion, cold like symptoms (nasopharyngitis) and back pain In rare cases, patients taking stendra and other PDE5 inhibitors may have erections for up to four hours or more, and sustained erections will not disappear If this happens, the patient should seek treatment immediately Three double-blind, placebo-controlled clinical trials confirmed the safety and efficacy of stendra A total of 1267 patients were randomly assigned to the stendra 50 mg, 100 mg, 200 mg dose group or placebo group for a trial period of 12 weeks, approximately 30 minutes before sexual activity At the beginning of the study and every four weeks thereafter, patients completed questionnaires to assess erectile function, vaginal insertion, and sexual success The results showed that the functional improvement at the end point was statistically significant in all three dose groups taking stendra Patients were recruited from two studies for another 40 week extension trial to further assess the safety of stendra Patients were initially given 100 mg of stendra, which could be adjusted to 200 mg or reduced to 50 mg depending on their individual response to the treatment The results showed that the commonly reported side effects in patients using stendra did not worsen over time Vivus, headquartered in mountain view, California, sells stendra Original link: http://