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Levitra News:

Levitra Helps Diabetics Not Helped by Viagra
posted 06/16/04

The impotence drug Levitra (vardenafil) proved effective for men with diabetes who had not been helped by Viagra (sildenafil).

Levitra shows fastest ever response time demonstrated of any PDE5 treatment tor erectile dysfunction

Treatment with Levitra can result in an erection in just 10 minutes in some men and in most men within 25 minutes. A new clinical study that measured the speed with which men with ED can achieve an erection demonstrated that Levitra has the most rapid onset to date of any PDE-5 inhibitor on the market. The study will be presented at the 7th European Federation of Sexology (EFS) congress in Brighton this week.

The study (called ONTIME - ONseT of Vardenafil In Men with Erectile Dysfunction), presented in the UK, showed that Levitra had a statistically significant response superior to placebo at 10 and 11 minutes with 10 mg and 20 mg doses, respectively. The ONTIME study assessed the earliest time elapsed from dosing to attainment of an erection adequate for penetration leading to completion of successful intercourse (as measured by SEP3 ).
"The results of the ONTIME study show Levitra demonstrated the fastest onset of action to date, meaning men can be confident and engage in a satisfying sexual experience when they want to," says Professor Francesco Montorsi, study investigator and Associate Professor of Urology at the Universita' Vita Salute San Raffaele in Milan.

In another study presented at the congress, speed of action was an essential attribute of ED treatment, more so than duration, according to the largest published survey of male sexuality (Men's Attitudes to Life Events and Sexuality [MALES]). This study found that in men with ED, rapid onset was considered important irrespective of age, while long duration of action became less important as men aged.

"The combined results of these studies demonstrate that men value a rapid onset of action and that Levitra offers patients what they want," concluded Professor Montorsi.
The MALES study included interviews with 2912 men, aged 20-75, from 8 countries (UK, US, Germany, France, Italy, Spain, Mexico and Brazil).

The ONTIME study was conducted in 724 patients in 80 centres in Europe and North America (8 countries). It was a randomised, double blind, parallel group, multicentre trial, which studied men with ED (baseline IIEF-EF score of 13.0 [moderate severity], ITT population ). The study design included a four-week unmedicated run-in period, followed by a four-week treatment with Levitra 10 mg, 20 mg or placebo, taken on demand. The first four doses were used to determine the earliest time of onset.

In the ONTIME study, the most common drug-related adverse events were generally mild to moderate and included headache, flushing, rhinitis and dyspepsia.

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. 2

It is estimated that some degree of ED affects more than one half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED. The number of men with ED is expected to more than double to 322 million by 2025. 3,4 , Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated. 5

Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human penile erectile tissue and is associated with erections. PDE-5 inhibitors typically work by blocking this enzyme to enhance or prolong the erectile response.

Levitra was specifically selected for development as an ED therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme.

Levitra 5, 10 and 20 mg doses are contraindicated in men taking nitrates and nitric oxide donors (a group of medications used to treat angina pectoris, or chest pain), in men concomitantly using HIV protease inhibitors (such as indinavir and ritonavir), and in patients with a known hypersensitivity to any component of the tablet. Please refer to individual country labels for other important prescriber information.

Levitra, researched and discovered by Bayer AG, is marketed by Bayer and GlaxoSmithKline plc (GSK) through a worldwide co-promotion and co-development agreement. Levitra was approved on 6 March 2003 by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The US Food and Drug Administration (FDA) approved Levitra for the treatment of ED on 19 August 2003.

Levitra does in 10 minutes what Viagra does in an hour!

London May 11, 2004 2:08:55 PM IST

A new sex drug is now giving Viagra stiff competition.
According to a study conducted by Congress of the European Federation of Sexology in Brighton, Sussex, the pill named Levitra, works in just 10 minutes.

On the other hand, Viagra takes an hour to set the mood for love, but can last for five hours if fellas have the energy.

Levitra was launched last year by drugs firms GlaxoSmithKline and Bayer.A team of Italian doctors tested 700 impotent men and found Levitra more effective.

"Levitra is a very, very fast acting drug. Ten minutes is an extremely short time," Leader Professor Francesco Montorsi, from Milan, was quoted by The Sun, as saying. (ANI)

Viagra Will Soon Be Facing Competition
Two New Drugs Expected to Give Men a Choice and Touch Off a Marketing War in the U.S.
By Marc Kaufman - Washington Post Staff Writer
Thursday, August 21, 2003; Page E01

With two new drugs poised to compete for the profitable market pioneered by Viagra five years ago, men who have trouble achieving erections will soon have choices that were unimaginable not long ago for a problem that most found difficult even to discuss.
While Viagra brought the issue of erectile dysfunction into the public eye, the new drugs promise to take the discussion further and make it far more specific. The makers of one drug have told physicians at conferences that men say the drug gave them more dependable erections than Viagra, while the staying power of the other is such that it has already been nicknamed "the weekender."

The maker of Viagra, Pfizer Inc., lost its monopoly on such drugs Tuesday when the Food and Drug Administration approved Levitra, made by Bayer AG and GlaxoSmithKline PLC. The agency is expected to act later this year on the application for Cialis, made by a partnership of Eli Lilly and Co. and Icos Corp. Both drugs have been widely marketed abroad and are competing with some success against the pioneer.

"This country is all about choice, and these new drugs add greatly to those choices," said Irwin Goldstein of the Center for Sexual Medicine at Boston University. "I can see men using one drug during the week when they want a shorter duration and another on the weekend for longer duration. . . . We can buy 86 different kinds of cars and so many different hypertensives and antidepressants, so why should there be only one drug for erections?"
Goldstein said that he is aware of two or three other erection drugs that are in clinical trials and that he expects the market to grow significantly during the decade. Just as Zoloft, Paxil and other antidepressants came to complement market pioneer Prozac in treating depression, he said, so will a wide range of related drugs follow Viagra, probably expanding the overall market as a result.

"As more and more of these drugs come on the market, the condition they treat is getting normalized," said Allen D. Seftel, a urologist at the University Hospitals of Cleveland who has run clinical trials on all three drugs. "Men will have choices and will be able to see which drug matches their needs. It's really a huge benefit for men with a problem that could barely be discussed not long ago."

Experts estimate that half of men over 40 have symptoms of erectile dysfunction. About one-tenth of them use Viagra.

As the new drugs reach pharmacies, men and their doctors will be able to discuss which best fits their needs and desires, and which side effects seem least unpleasant.

Viagra has got a huge head start, having had the market to itself for more than five years and being used by as many as 20 million men. A Pfizer spokesman said the drug earned $1.73 billion worldwide last year -- with more than $1 billion of that in the United States -- and the company expects it to remain dominant.

Like Viagra, Levitra increases the blood flow to the penis and so encourages distention for 41/2 to eight hours. Levitra delivers a smaller and more biologically precise dose of its active ingredient than Viagra, and as a result, its advocates say, it has fewer side effects -- such as flushing, headaches and a stuffy nose. They also say it appears to improve the quality of erections.

In a news release yesterday, Bayer and GlaxoSmithKline said Levitra had been tested in more than 50 trials involving more than 5,700 men. The release emphasized Levitra's speed and reliability.

The other drug on the horizon is Cialis, which was deemed "approvable" last year by the FDA. Its manufacturers had initially expected to win approval to market it in the United States before Levitra did, but the FDA asked for additional evidence and its review has taken longer than initially expected.

The greatest difference between Cialis and the other two drugs is that it works in the body for 24 to 36 hours; thus the nickname "the weekender." That difference will be the focus of the U.S. marketing war expected in the months ahead, as it has been abroad.

"Many men have reported that they don't like the pressure put on them by the relatively short time that Viagra works," said Carole Copeland, spokeswoman for Eli Lilly. "They say that Cialis returns them to a more normal pattern of sexual life. They will be ready when the urge is there, whether it's Friday night or Saturday or even Sunday."

But Daniel Watt, a Pfizer spokesman, said most men won't want to have a powerful drug in their bodies for a longer time than needed. "Although the other medicine may last longer, the fact is that most sexual activity occurs within a relatively short time of the initial thought, and within a four-hour time span. To have a drug in your body for time you might not need it, is maybe not a good thing. . . . I don't think most men want a drug that won't clear up for 72 hours."

The new drugs work the same way Viagra does, by limiting the action of an enzyme called phosphodiesterase-5, or PDE-5. The enzyme works as a brake on the molecular events that lead to an erection, so when there is less of it at work in the body, a man finds it easier to achieve an erection. With all three drugs, the response occurs only when a man is sexually stimulated.

Viagra costs about $8 to $10 a pill. Some analysts predict that the rival manufacturers will price their products lower than that, but others said the firms will probably promote their drugs on their different characteristics rather than cost.

GlaxoSmithKline has signed former NFL player and coach Mike Ditka to be the spokesman for Levitra, Reuters has reported. Viagra's spokesman initially was former presidential candidate and Senate majority leader Robert J. Dole (R-Kan.) and now is baseball player Rafael Palmeiro of the Texas Rangers

NEW STUDY SHOWS LEVITRA® (vardenafil HCl) STARTS TO WORK IN AS EARLY AS TEN MINUTES IN MEN WITH ERECTILE DYSFUNCTION (ED)

No Other Oral ED Treatment Has Been Proven to Work as Fast as Levitra
West Haven, Conn., and Philadelphia, Pa., May 10, 2004 – According to the results of a new study, some men with erectile dysfunction (ED) can now achieve an erection in as few as 10 minutes with LEVITRA® (vardenafil HCl).(1) These findings were presented at the 7th Congress of the European Federation of Sexology (EFS) this week. In a separate retrospective analysis of two studies, Levitra was shown to provide a favorable window of opportunity of up to 12 hours.

“I treat many men with ED, and for some, rapid onset is an important consideration in an oral ED treatment,” said Marc Gittelman, M.D., founder and director of the Miami Center for Sexual Health and voluntary assistant professor at the University of Miami School of Medicine. “These new Levitra data are important because it is the first time any oral ED treatment has been shown to work in as early as 10 minutes. I think this is exciting news for men with ED who are looking for a treatment that is reliable, fast and provides a quality response.