The 14-member FDA advisory committee, plus voting consultants, for Reproductive Health Drugs unanimously rejected Proctor and Gamble's (P&G) fast-track request for Intrinsa, a transdermal testosterone targeted for surgically menopausal women.
A P&G blinded exit interview of 132 patients from the two pivotal trials found a 52% to 31% meaningful response rate among the women treated. In a vote of 14 to three, the committee agreed that Intrinsas effect was clinically meaningful.
However, the committee cited the potential for off-label use as one reason for rejecting the application.
"I think that in light of the potential for off-label use for this product, we must have information from premenopausal women and menopausal women. We must have information from women who are not only taking estrogen, but women who are taking estrogen with progesterone," commented committee member David Hager, MD (University of Kentucky).
Hager's comments reflected concerns cited in The Street. K. Noelle Tune of Leerink Swann & Co. was quoted as being concerned that "the conservative nature" of some committee members might affect the panel vote, causing them to be reluctant to approve a so-called "lifestyle" drug.
There were a myriad of other possible risks cited, such as possible fetal impacts (the drug is for women who have no ovaries), heart disease, and breast cancer.
News reports have cited the Women's Health Iniative (WHI) as a cautionary tale and have mischaracterized its results as 'increased risk of strokes for post-menopausal women who take estrogen.' The drug tested in WHI was not estrogren, it was a non-bio-identical estrogen which is created from pregnant mare's urine. There have been no such clinical trials for bio-identical estrogen, which is available via a transdermal patch like that used for Intrinsa.
News reports have also quoted two men -- one consulting member and one permanent member -- but no reports have quoted the committee chair, Linda Giudice MD/PhD, Stanford University Medical Center.
Whether this decision is politically-, medicially-, or CYA-based is not clear. The FDA has come under heavy criticism recently for approval of drugs which, at least in hindsight, seem highly questionable.
According to a P&G spokesperson, 20-25 percent of the 25 million women in the US who are surgically menopausal, the group targeted for this drug, are "distressed by their lack of sexual desire."
Another 10 percent of the 30 million naturually post-menopausal women are also distressed.
Intrinsa would be the first FDA-approved drug to treat hypoactive sexual desire disorder in women with surgical menopause. There are many other female sexual disorder products being tested as patches, pills, gels, creams, and nasal sprays.
In neighboring Canada, post-menopausal women have been able to obtain government-approved testosterone treatment for at least two years.
Down-under, in Australia, post-menopausal women can use Organon testosterone implants. The downside is that are surgically inserted, and the testosterone lasts from three to six months. A convenient delivery mechanism like the transdermal patch would make this accessible to more women.