Avanafil news and information

What is Avanafil

New ED drug may work in 15 minutes

Look out Viagra – there’s a new erectile dysfunction drug in town.

It’s called Stendra (aka Avanafil) and it’s newly approved by the Food and Drug Administration, making it the first ED drug to come out in almost 10 years. The FDA declared 3 clinical trials involving 1267 patients established the safety and effectiveness from the new drug. These were randomly assigned to adopt various doses of avanafil or perhaps a placebo for up to 12 weeks. Patients receiving avanafil reported significant gains in erections, vaginal penetration, and successful intercourse.

avanailAlthough Stendra has not been tested against what is known as the “Little Blue Pill,” drug makers say that – for some men – it may work faster.

“If things are heated up, theoretically you can get improved function earlier, within 15 minutes, with this drug,” 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.”

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.

Goldstein, who has authored more than 300 studies in the field of sexual dysfunction, said that early data suggests Stendra may perform faster than other ED drugs, but that must be proven in a larger, real-world population.

Goldstein and his team studied 1,267 men who took a 50, 100 or 200 milligram dose of Stendra – or placebo – about 30 minutes before engaging in sexual activity.

The men filled out questionnaires indicating, for example, how long it took before they engaged in sexual intercourse or became aroused.

“For some men it works in 15 minutes, for some men it took longer,” said Goldstein.

To be clear, no one is suggesting that men should drop Viagra – or any other of the popular ED drugs– for Stendra.

“There is no drug that is the best,” said Dr. Laurence Levine, a professor in the department of Urology at Rush University Medical Center in Chicago, who was not a part of the Stendra study. “Each patient’s own chemistry may make one drug better than another. There are certain advantages and disadvantages to all of these drugs.”

Stendra is another option in a field of effective and safe drugs, said Levine.

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.

The erectile dysfunction marketplace could get its first new entry in almost a decade with the experimental drug Avanafil, a faster-acting pill in the same class as Viagra, Levitra and Cialis, reportedly with fewer side effects.

European approval closer

VIVUS inc. announced in April, 2013  that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorization for avanafil (SPEDRA™) for the treatment of erectile dysfunction (ED) in the European Union. The CHMP recommendation will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. A final decision from the EC regarding the SPEDRA Marketing Authorization Application (MAA) is expected within approximately two months.

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.

The most recent FDA approval of an ED drug came in 2010 for Staxyn, a version of vardenafil that dissolves under the tongue, rather than being swallowed.

FDA approval

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.

Avanafil 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.

Avanafil Brand Names

Avanafil is marked by Vivus under the brand name Stendra.

What are Avanafil 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.

Stendra (Avanafil) side effects in clinical trials so far seem to be fairly mild, mostly composing of headaches, flushing, back pain, and nasal congestion.  Keep checking back regularly as we will be updating the side effects of Stendra (Avanafil) as soon as we receive more information.

Who Makes Avanafil

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.  Vivus received FDA approval for a new weight loss drug called Qsymia in July, 2012.

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