An experimental drug for low libido in women may yet find a way to earn FDA approval. Flibanserin failed to receive a green light last year because the agency determined that the drug’s effects were too modest to offset its side effects such as dizziness, nausea and drowsiness. Nearly 10 percent of the women who took flibanserin in clinical trials reported that it made them sleepy.
Women’s advocacy groups complained that the Food and Drug Administration is applying stricter standards for this women’s drug that it has for the 24 medications it has already approved for male sexual dysfunction. The inconsistency in standards has groups like the National Organization for Women and the Center for Health and Gender Equity protesting to the leadership of the FDA.
The manufacturer now has been invited to conduct three additional studies. Two of these will consider flibanserin interactions with other drugs, while the third will evaluate whether the somnolence induced by the medicine makes driving too dangerous.