FDA Approves New Impotence Drug Stendra
Like Viagra, Cialis and Levitra, Stendra is a pill, and is in a class of drugs called PDE5 inhibitors. These work by increasing blood flow to the penis. Patients can take Stendra as needed 30 minutes before sexual activity, the FDA said in a statement released Friday.
Stendra (avanafil) joins Viagra, Cialis and Levitra, all from a class of drugs known as phosphodiesterase type 5 inhibitors that help boost blood flow to the penis.
According to the FDA, fast-acting Stendra is designed to be taken 30 minutes before sexual activity and at the lowest effective dose.
Whether the new drug adds any value to the existing range of impotence medications is unclear, one expert said.
Dr. Bruce Kava, acting chairman of urology at the University of Miami School of Medicine, said that "the only advantage Stendra may have is a more rapid onset of action over the other drugs. The question is whether there are any advantages to a more rapid onset."
He noted that many patients don't respond to one or another of these drugs. But there is no way right now of telling who will respond to which drug. "Sometimes it's hit or miss," he explained.
Men will have to try these drugs to find the one that best suits their lifestyle, Kava said. For example, for some men Cialis works best because its effects seem to last much longer than that of the other drugs, he said.
The FDA said Stendra's approval means one more option for patients.
"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 a statement.
Stendra comes with the same warnings as its companions in this drug class. It should not be taken by men who take nitrates -- drugs used to treat chest pain (angina). This combination can cause a sudden drop in blood pressure, the FDA cautioned.
The agency also warned that these drugs can, in rare cases, cause color vision changes and in rare instances, men have also reported a sudden loss of vision in one or both eyes. Sudden loss or decrease in hearing has also been reported in patients taking these drugs. "Patients who experience a sudden loss of vision or hearing should stop taking PDE5 inhibitors, including Stendra, and call a doctor right away," the FDA said.
The most common side effects reported with Stendra include headache, redness of the face and other areas, nasal congestion, cold-like symptoms and back pain.
In rare cases, patients taking these drugs may get an erection lasting four hours or longer that will not go away. "If this happens, patients should seek immediate medical care," the agency said.
Erectile dysfunction occurs when a man has trouble getting or maintaining an erection. An estimated 30 million American men in are affected by erectile dysfunction, according to the FDA.
Stendra's safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients were randomly assigned to take Stendra for up to 12 weeks at doses of 50 milligrams (mg), 100 mg or 200 mg, or a placebo as needed about 30 minutes before sexual activity.
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 FDA’s 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.
"Patients and treating physicians continue to report significant dissatisfaction with current treatments of ED. We believe that the PDE5 selectivity and absorption profile of STENDRA make it an important new treatment option for many men with erectile dysfunction”, Peter Tam, the president of Vivus, said in a press release.Unlike Viagra that takes about an hour to start working, Stendra takes about half that time and according to some reports as little as 15 minutes. This gives Stendra an edge over other competitors like Viagra, Cialis and Levitra.
“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 Kuslak deputy director of the Office of Drug Evaluation in the FDA’s Center for Drug Evaluation and Research said in a news release.
It is estimated that 30 million men in U.S suffer from erectile dysfunction.Stendra belongs to a class of PDE5 inhibitors that are used to increase blood flow to penis. PDE5 inhibitors might cause blindness or hearing loss. Also, FDA advises men who take nitrates to avoid taking Stendra as it can cause sudden drop in blood pressure.
In clinical trials to test the efficacy, Stendra and a placebo were randomly assigned to 1,267 patients. The doses of Stendra given were 50 mg, 100 mg and 200 mg. the participants were asked to take the tablets 30 minutes before sexual activity. The test period was about 12 weeks after which patients were asked to fill in a questionnaire before the start of the test and every four weeks to evaluate the effects.
Results showed that there was improvement in erection, vaginal penetration and successful intercourse in patients who took Stendra compared to those on placebo.
The side effects of using Stendra included headache, redness of face, back-pain etc. The tests showed that the side-effects did not worsen further. Vivus recommends that Stendra should be taken only once in a day.
VVUS reported that the FDA has approved STENDRA tablets for the treatment of erectile-dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition th ..