Posted on 06/16/2004 3:51:51 PM PDT by freedom44
NEW YORK (Reuters) - Procter & Gamble Co. on Wednesday moved a step closer to becoming the first company with a drug on the market to treat sexual dysfunction in women after releasing data from a pivotal late-stage clinical trial that backs up its previous findings.
The testosterone skin patch, to be called Intrinsa, significantly improved sexual desire and satisfaction in women whose ovaries had previously been removed, according to data to be presented on Friday at the Endocrine Society of America annual meeting in New Orleans.
Armed with data from two large phase III clinical trials that appear to demonstrate safety and efficacy of Intrinsa, P&G believes it now has the information needed to seek approval from U.S. regulators.
Although the company declined to discuss when it would file its new drug application with the Food and Drug Administration, P&G spokeswoman Mary Johnson said if approved they hope to have Intrinsa available by prescription sometime next year.
The drug would be prescribed to increase sexual desire in menopausal women who have experienced loss of desire and are distressed by that loss.
"This is huge," said Sheryl Kingsberg, an associate professor of reproductive biology at Case Western Reserve University and one of the lead investigators of the trial.
"It's important to get it out there because we don't have any approved medical treatment on the market for female sexual dysfunction that clinicians can look at as safe and effective," Kingsberg said.
In P&G's latest 24-week trial of 533 women, patients taking Intrinsa reported a 51 percent increase in frequency of "satisfying sexual activity" and a 49 percent increase in sexual desire, compared with their previous experience.
The response rate was lower than in a previous trial, but researchers said the findings were statistically significant.
In a similar study of 562 women released in May, women receiving the patch had a 74 percent increase in frequency of satisfying sexual activity and a 56 percent increase in sexual desire.
P&G, best known for consumer products such as Tide laundry detergent and Crest toothpaste, said it is currently conducting two more late-stage clinical studies of the testosterone patch in menopausal women who have not had surgery to remove their ovaries, Johnson said.
The search for a so-called female Viagra has so far proved elusive. Even Viagra-maker Pfizer Inc. abandoned their program of testing the drug for women, whose sexual dysfunctions are more varied and complicated than men. "In any area of research, women's research always lags behind men," Kingsberg said.
Analysts have said drugs for female sexual dysfunction that prove effective in treating problems with desire, arousal or ability to achieve orgasm could garner sales in excess of $1 billion a year.
Vivus Inc. is developing a drug to treat the arousal component of female sexual disorder that it hopes to submit to the FDA in 2006. It also acquired rights to a female sexual desire treatment that may compete with Intrinsa.
"The launches of these drugs, starting with Intrinsa, will prompt a wave of marketing that will likely raise awareness of Female Sexual Dysfunction," David Lapidus, analyst at Decision Resources, said in a report.
Are you kidding me? So now the pharmas have the green light to mfg spanish fly? hmmm. I smell lawsuit.
But will women with hairy lips and chests benefit anyway?
dinner and drinks...
Now if they can get this stuff into a tube of toothpaste, that would be great. Or maybe an easy-dissolve pill, this could take the place of Ruhypnol (date-rape drug)
Maybe I should get married after all...
There is a solution for the hair, comes in a tube I think!
Porn Stars, prostitutes, brothel owners, white slave traders, and want-to-be Sex In the City types around the world are rejoicing. What ever happened to the ideal of virtuous women?
A pill for each and then let the good times roll!
Oh, great. We have all those miserable "erectile dysfunction" commercials stinkin' up the place. I hate the one with the chunky old guys skipping down the street. And now we'll have the finest creative minds in advertising turning themselves loose on the dames...
An interesting evolution indeed.
Will women who use this all start sounding like Bea Arthur?
First there were the Viagra, Cialis, and Levitra ads. Then there were the Ortho-Tricycline ads, and now this.
-PJ
Anything wrong in using this within a marriage? That's where my informal research shows the product is most needed!
That's another way...
Free sample of Intrinsa in every box of Tide?
Gives new meaning to riding the dryer.
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