The deal comes two days after US regulators approved the pill Addyi, a milestone for the drug industry that could revive interest in medications for women’s sexual problems.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option”, said Janet Woodcock, M D, director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research.
“This is a transformational moment, hopefully across all of women’s health care, certainly in women’s sexual health”, Cindy Whitehead, chief executive officer of Sprout, said.
The FDA has been analyzing, observing, debating, overanalyzing and reached the conclusion that the pink pill, namely the female Viagra, deserves an approval.
Those medications, which include Viagra, are designed to increase blood flow to the genitals and are meant to be taken shortly before intercourse. This partnership with Valeant allows us the capacity to now ensure broader, more affordable access to all the women who have been waiting for this treatment.
In a dedicated alcohol interaction study, 17% of 25 patients taking Addyi, and drinking the equivalent of two five-ounce glasses of wine over a 10-minute period, required therapeutic intervention, such as smelling salts.
However, Addyi had previously been rejected twice by the FDA due to lackluster effectiveness and side effects.
Said Utian: “It may improve sexual desire, but it’s not like a home run drug – it’s more like a first base drug”. But for critics, it represents both a new “hysteria” and a new “restless leg syndrome” – a disease created because there is a profit in curing it, and another way for experts to tell women their sexuality isn’t OK. Mixing the pill with alcohol could cause dangerously low blood pressure and fainting.
The drug, Addyi, will be prescribed for patients with a condition known as acquired, generalised hypoactive sexual desire disorder (HSDD), or sudden and severe loss of libido. The end-goal of taking Addyi on a daily basis is that it will eventually change a woman’s sexual mood to where she will feel more inclined to take the initiative rather than avoid sex.
“Beyond building this in the United States, Valeant also offers us a global footprint that could eventually bring Addyi to women across the globe”, she said.
There has been much talk lately about the potential release of a new female libido drug, but while the main discussion has been about the relevance of the medicine, some discussion must also be underway to identify diagnostic criteria for this drug.
While sometimes referred to as the “female Viagra”, the drug differs from that drug, which targets erectile dysfunction, a physiological problem.
Sprout said a one-month supply of the drug is estimated to come with a $30 to $75 co-pay per month for patients.