[In this case, what’s good for Proctor & Gamble is also good for BioSante, whose LibiGel is a more user-friendly product than P&G’s patch (#msg-4099149).]
NEW YORK, Oct 8 (Reuters) - Procter & Gamble Co. (PG) on Friday said its experimental testosterone skin patch significantly improved sexual desire in naturally post-menopausal women in a late-stage clinical trial.
The patch, called Intrinsa, has already been submitted to U.S. regulators as a treatment for reduced sex drive in women with menopause triggered by surgery and was granted priority review. P&G expects Intrinsa to be approved and available to those women sometime next year.
The new data, however, could vastly increase the size of the population that can use Intrinsa and potential revenue if it is eventually approved for naturally menopausal women.
"Our estimates show that in 2005, there will be 10 million surgically menopausal women and 30 million naturally menopausal women," said Procter & Gamble spokeswoman Mary Johnson.
The patch, developed with Watson Pharmaceuticals (WP) , is designed to treat women distressed by a lack of sexual desire after menopause.
"It is the first time there will be a medical option for women with sexual dysfunction," said Sheryl Kingsberg, an associate professor of reproductive biology at Case Western University and one of the lead investigators of the trial.
Analysts have said drugs for female sexual dysfunction that prove effective could garner annual sales in excess of $1 billion. So far, the search for a so-called female Viagra has proved elusive.
The latest 24-week study of 549 women, to be presented at the North American Menopause Society's annual meeting in Washington, reported a statistically significant increase in sexual desire and satisfying sexual activity and a decrease in distress among those using the testosterone patch, compared with their prior experience and those taking a placebo.
Women using Intrinsa experienced a 48 percent increase in desire over their "baseline" experience prior to the study, compared with a 20 percent increase in those who received the placebo. Those using the patch reported an average of 1.9 satisfying sexual experiences per four weeks, compared with 0.5 in the placebo group. The patch users also reported a 52 percent decrease in distress, researchers said.
"The study is incredible because it addresses a much larger population and it is really confirming of the other surgically menopausal trials, so you have a one-two punch here," Kingsberg said. "Replacing testosterone in the naturally menopausal women works very similarly."
She said the patch "doesn't create sex-craving nymphomaniacs, women in these trials are simply asking to restore the desire they had prior to menopause."[This would appear to be a non-issue given the rate of only 1.9 satisfying sexual experiences per month in the treated group.]
P&G is currently conducting another pivotal late stage trial of more than 500 naturally menopausal women that they hope will confirm the results presented on Friday and help make the case for wider FDA approval.
"As the results of both become available we will be in discussion with the FDA," Johnson said. <<
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