"Pink Viagra"

"Where are the crowds of women with low libido clamouring for Addyi?"
"They never existed, except in a public relations firm's fantasy."
PharmedOut, Georgetown University Medical Center, Washington

"The FDA is being responsible ... yes."
"[However], some people are now arguing REMS [risk evaluation and mitigation strategy] was a scare tactic the FDA imposed because it didn't particularly like being dragged back into this whole debate about whether HSDD [hypoactive sexual desire disorder] is truly an unmet medical need."
"[Female sexuality is] a much more sophisticated process [than what Viagra overturns by increasing blood flow to the penis]."
Dr. Jim Pfaus, professor of psychology, Concordia University, Montreal

The Food and Drug Administration on Tuesday, Aug. 18, 2015, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the ockbuster success of impotence drugs for men. AP Photo/Allen G. Breed

Professor Pfaus has a personal interest in the debate, having led some of the earliest studies to determine effects of flibanserin [Addyi] on female rats' sexual desire and resulting copulation. And while he conducted research for the Canadian Institutes of Health Research, he also was in receipt of consulting grants from Addyi's original formulator, Boehringer Ingelheim, before it was bought out by Valeant Pharmaceuticals International, headquartered in Quebec.

There are those who claim that governmental drug regulators have set up barriers for access to this 'pink Viagra', restricting access by requiring doctors and pharmacies to obtain certification to prescribe or dispense the pills. Instructions that accompany the drug include the warning that women using it must never drink alcohol while using the drug, which has the capacity to cause low blood pressure and syncope, a sudden loss of consciousness.

When Sprout Pharmaceuticals obtained FDA approval for the Addyi it was producing, realizing success on the third try after the drug had seen rejections over safety concerns, Valeant bought the copyrighted formula along with the company itself for $1-billion. That gamble rested on the assumption that Addyi would turn out to be as successful on the consumer market as its male predecessor has been.

However, there is a world of difference between the two drugs' interaction with the human body; Viagra's effect was mechanical, while Addyi's is psychological, in essence sending its message to the brain. Addyi must be taken daily, unlike Viagra whose calculated use is just before sex, to increase blood flow to the penis. Unlike Viagra which sold over a half million prescriptions in its first month on the market in 1998, a mere 23,000 prescriptions were dispensed for flibanserin in the U.S. since 2015.

When it was approved in August 2015 by the U.S. Food and Drug Administration, it was said to be with the proviso that advertising on television or radio not take place for the first year-and-a-half of its commercial availability. In Canada the drug remains in uncompleted review status by Health Canada, though it had been submitted over a year ago for approval. Critics of the drug feel its lackadaisical uptake reflects women's unwillingness to use Addyi.

It comes at quite the cost; $800 (U.S. monthly), and nor is its effect particularly assured. It is recognized as a risky drug which produces an average single extra "sexually satisfying event" per month more than would a placebo replacement. Valeant is now free to begin advertising its controversial wares through "education awareness" campaigns to convince women that their sex problems are commonplace, and they can rely on a pill to achieve the quality of sex they deserve.

Sex on the brain -- Irving Penn

Their public relations advertising campaign is entitled Find My Spark, offering a sex health quiz and video clips where doctors who see women with low sex drive empathize with those who feel "inadequate -- as a woman, as lovers and as partners". "Information" campaigns with subtle messages such as: "that it is imperative that women be sensitized to this public health problem" are now on the horizon.