Though the drug was submitted to the FDA twice, it was not approved due to the side-effects which include nausea and dizziness.
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In addition, the FDA has asked the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.
The move to approve the drug called Addyi for sexual dysfunction in women was made after years of clinical trials.
[A] once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
“It’s complex. It’s not the same as a man taking a pill”. The company will refrain from advertising directly to consumers for 18 months, to avoid creating a clamor for the new drug. The company will focus its 200 sales representatives on promoting the drug to medical specialists. Essentially, the warning tells women that if they drink alcohol while they’re on Addyi, they might faint and hit their heads.
Flibanserin needs to be taken every day.
While the FDA has approved numerous treatments for sexual dysfunction in men, the agency has been accused of gender bias for failing to approve any such medications for females.
While the FDA is required to make all decisions based on science, critics say that the concerted lobbying effort by Sprout-funded supporters also played a role in Addyi’s approval.
“If you have a broken leg, a broken toe or a broken libido, you can now go to a doctor and get help”, he says. That same risk can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
For now only trained physicians will be allowed to write prescriptions for the pill which should never be taken with alcohol.
About 2 million women are now seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.
“Just because a woman has an increase in sexual encounters, the question was, is she satisfied?” “For far too long we’ve reduced all things in the bedroom for men to biology, as witnessed by countless treatment options, and we’ve reduced all things for women to psychology”, Cynthia said. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. According to trial results, women treated with the Sprout drug reported between 0.5 to 1 additional sexually satisfying event per month, compared against patients who received a placebo.
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After the first rejection, Boehringer Ingelheim abandoned the drug.
