FDA Looks at P&G's Sex-Drive Drug

Updated from 10:33 a.m. EST

Staff members of the Food and Drug Administration on Wednesday issued a report raising several questions about an experimental drug from Procter & Gamble(PG Quote) designed to improve sexual desire in menopausal women whose ovaries have been surgically removed.

The report, which asks questions about P&G's data as well as potential safety issues, comes one day before an FDA advisory committee meets to review the drug called Intrinsa. It's a transdermal patch that transmits the hormone testosterone. The FDA staff routinely issues a report a day before advisory committees meet, asking the panels to examine a range of safety, efficacy and testing issues based on the companies' applications.

Sometimes the staff recommends approval of a product; sometimes it recommends rejection. For Intrinsa, the staff made no recommendation on a drug that many analysts say could become a female equivalent of Viagra, the erectile dysfunction drug made by Pfizer(PFE Quote).

The FDA isn't bound by its advisory committees' opinions, but the agency usually follows their recommendations. Intrinsa would be the first FDA-approved drug to treat hypoactive sexual desire disorder, and its approval could clear the path for a host of other female sexual disorder products now being tested as patches, pills, gels, creams and nasal sprays.

Although P&G is seeking Intrinsa's approval for surgically menopausal women, analysts say a much bigger market would be naturally menopausal women. P&G is conducting late-stage clinical trials for this larger group. But if the FDA approves the drug for the smaller group, analysts expect some "off-label" use by other women. Once the agency approves a drug for one disease or condition, doctors can prescribe it for other uses.

Analysts caution, however, that the drug could face some political as well as medical hurdles. Another big issue is how many insurers will pay for its use.