What is Stendra
U.S. Government approves new ED drug
Look out Viagra – there’s a new erectile dysfunction drug in town, it works in 15 minutes and is safer.
It’s called Stendra® (aka Avanafil) and it was approved by the Food and Drug Administration in April 2012, making it the first ED drug to come out in almost 10 years. 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. In some men in the right situation, it might even work in less than 15 minutes said Dr. Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego, and co-author of a recent study about Stendra in the Journal of Sexual Medicine.
“You can argue this is the first potential on-demand drug,” says Goldstein. The “on-demand” drug could end up in high demand for men with ED who do not respond to drugs like Viagra, Cialis and Levitra.
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.
But do we really need another Viagra?
“No, we don’t need another Viagra, but competition is good. We need to see a reduction in the cost to the consumer of these drugs, and this is not exactly another Viagra,” said Dr. Ira Sharlip, a urology professor at UC San Francisco and former president of the International Society for Sexual Medicine. “I say this because the onset of action seems to be faster than Viagra, although there are no head-to-head studies of onset of action.”
The little blue pill Viagra (sildenafil) started a late 20th century sexual revolution by destigmatizing impotence, and replacing that term with “erectile dysfunction,” or ED in the popular lexicon. Like Viagra and its competitors Levitra (vardenafil) and Cialis (tadalafil), all of which are regularly advertised on television, Avanafil increases blood flow to the penis to help men achieve and sustain an erection. But its main selling point may be that clinical trials suggest it can produce an erection in as little as 15 minutes.
“Quick onset of action is important to men,” especially a subset of patients seeking treatment for erectile dysfunction, Sharlip said.
“Men who have a pattern of sexual activity that’s predictable — every Saturday night, or something like that, don’t need this. Those whose opportunities for sexual activity are more casual will like it,” Sharlip predicted. “If you see that things are heading in that direction, you pop a pill and are ready in 15 minutes, if correct.”
The studies also indicate Avanafil clears the body more quickly than the other ED drugs in the same class, the phosphodiesterase type 5 / PDE5 inhibitors, according to data submitted to the FDA by Vivus Inc. The pharmaceutical company also is behind the diet drug Qnexa, which remains under FDA review.
In a Phase II study, Avanafil worked as well as Viagra while producing less low blood pressure in cardiac patients who take nitroglycerin. In the two Phase III trials that compared Avanafil with 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.Sharlip said he didn’t believe that those rare side effects matter much to most patients. “Despite what the FDA says, I have never seen priapism from any PDE5 inhibitor drug. Priapism is just not a clinical problem. Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it,” he said.
The most common side effects of Avanafil in studies to date were headache, flushing, stuffy nose, mild cold symptoms and back pain.
The FDA has approved Avanafil. Vivus, based in Mountain View, Calif., licensed rights to the drug from Mitsubishi Tanabe Pharma Corp. Avanafil has also been approved for use in Korea.
Vivus, Inc announced on April 27,2012 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.
Stendra vs Viagra
In addition to being quick to take effect, avanafil leaves the blood stream quicker than viagra, which may indicate that there will be fewer side effects Cialis(tadalafil), levitra (Vardenafil) and Viagra (sildenafil citrate). What those side effects may be is still uncertain, but, like users of similar drugs, avanafil trial users have reported some headache, flushing, back pain, and nasal congestion.
Avanafil also appears to be better than Viagra at concentrating its activity on PDE-5. This is important because PDE-5 is a protein which interferes with the body’s natural signals to relax the smooth muscle cells in the penis, thereby shutting off blood flow into the erectile tissue. The more effective a drug is in inhibiting PDE-5 , the more likely it is that a man will be able to achieve an erection.
What are Stendra® side effects and risk
The company claims that Stendra (Avanafil) works in 15 minutes, compared to the average competitors 30 minute window. With the drug working quicker, it also leaves your blood quicker than the other similar drugs on the market, therefore possibly reducing the amount of side effects.
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. 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).
A small minority of patients experienced side effects after taking Stendra, according to the study, including headaches, flushing, nasal congestion and back pain. And overall, patients taking any ED drug – all of which work similarly – should be aware of rare side effects like sudden loss of vision or hearing, according to the FDA.
Natural Alternatives to Stendra
There are several effective natural herbal supplements to treat erectile dysfunction and provide male enhancement. Most of these are based on traditional herbal remedies or a combination of several herbs. The most powerful herbs are Dong Quai, Astragalus, Tongkat Ali, and Maca. It is estimated that men spend over $30 billion world wide on over the counter ED supplement. The leading natural ED supplements are Endurnz, Extenze and Enzyte.
Who Makes Stendra®
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. Vivus‘s avanafil is licensed from Mitsubishi Tanabe Pharma. It has been recently been accepted by the European Medicines Agency. Avanafil has also been approved by the U.S. FDA. Analysts project annual sales for Stendra to be $300 million next year, compared to the $2 billion Pfizer netted in 2011 for Viagra sales.