You know it truly isn't 1984 but must be 2015 when you hear on a quiet Tuesday evening in high summer that the FDA has (finally) approved the first drug specifically designed to increase female libido. Now, we all know that the little blue pill has helped improve male sexual health enormously (no pun intended!), even if Viagra has less to do with libido than actual capability, but still - it was time for women to get in on the game too!
The approval of Sprout Pharma's Addyi™ (flibanserin) came after two previous rejections by the agency and it is also burdened by quite a bit of controversy, not least of which are serious questions surrounding the drug's safety and efficacy. Although there has been mounting pressure on the agency to approve this drug, detractors cite both the only modest effects in many responders, coupled with major safety concerns over incompatibility with alcohol.
We all know that ethanol itself is often used as a prelude to the boudoir (if not as an actual readily available form of aphrodisiac drug) and so the reports of spontaneous fainting (!) and wooziness observed are more reminiscent of Rohipnol than a wonder drug. One can only imagine the black market and potential for abuse on this one, especially if the fainting can be more relied upon than any effect on libido. It's a little worrying, to say the least.
Another reason for the burgeoning controversy has to do with the lobbying of the FDA that has transpired, actually placing the issue as not so much one of drug approval, but one of basic gender inequality and lack of fair play in the dimly lit and often-silent corridors of power at the FDA. This lobbying was most preeminent via an online social media campaign known as "EVEN THE SCORE", which represents an organization whose purpose is to "level the playing field when it comes to women's sexual dysfunction". That the campaign did have significant impact is not only mirrored by the FDA's approval this week, but also in the comments made by Dr. Janet Woodcock, the director of FDA's CDER division -
"Today’s approval provides women distressed by their low sexual desire with an approved treatment option. The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction."
Sentiments I think we can all agree with, even if the key words remain "safe and effective", and there's the rub (no pun intended!) so to speak. Many seem to feel that the FDA felt huge pressure to approve the drug on this go-around; significant enough pressure to actually go soft on those two extremely important words when it comes to drug development and marketing approval. Safe. Effective. The FDA clearly acknowledges the weakness in the former word by requiring prescribing physicians to warn women of the potential dangers of mixing alcohol into this particular sexual chemistry equation, but that only goes so far to assuaging concerns.
At the time of the approval, it seems that Sprout Pharma is a rather lean and mean affair, with a mere 34 employees; this number is now expected to swell to 200 before year end. Clearly, marketing is now going to take over, big time, and even if clearly controversial in that regard, it is an area that Sprout seems to understand well. The entire lobbying and push for Addyi™ 's approval via the use of eye-catching and thought-provoking social media, coupled with putting the issue of gender inequality front and centre, definitely raised their profile and accelerated what could have been a much longer process. Having said that, the individuals involved have incurred the wrath of the FDA in their previous lives.
Bob and Cindy Whitehead, founders of Sprout Pharma, came under the radar of watchdogs at the FDA back in 2010, when at Slate Pharma (precursor to Sprout) they were accused of exaggerating the benefits of a testosterone-related drug that were not in compliance with the drug's label. Their overtly and overly aggressive marketing tactics drew an 11-page letter from the agency telling them to tone things down or face further action, which quite naturally, has raised eyebrows not only at this approval, but over just how far they are going to go with the marketing campaign on this one!
Somehow, I can't see the FDA laughing too raucously (outside of the safe confines of their offices, anyway) at any suggestions that the purpose of any sexual dysfunction drug (male or female) is to make you feel "as randy as a teenager". Maybe they might have to tone the videos down a little, at least in the roll out of Addyi™ ! In that regard, based on prior experiences with this team, it seems that the FDA got Sprout Pharma to agree to hold off on TV advertising for the drug for a full 18 months following approval - which kind of says it all, in effect.
In any and all cases, while there are as many as some 25 different products that can potentially positively impact men's sexual health on the market, to date there have been none for women, so FDA approval of a female equivalent is most definitely desirable (no pun intended!), timely and warranted. I guess the big question in men's lives may be how it actually will feel to have the tables turned, whereby it is their wives/girlfriends who have the stronger libido and who become more demanding in the bedroom!
Men have had it too easy and for too long, they say, and if this drug does work as well as supporters would love to claim, then it may be men's lives that will be changed forever, not just women's! What goes around comes around, and history often repeats itself - who knows, we may even see the return of an ancient expression - "Not tonight, Josephine!"
PS Hot on the heels of finishing this one, I just heard that Valeant didn't lose any time following the approval of Addyi™, and announced mere days later that they will add some green into this equation - via acquiring Sprout Pharma for a whopping $1B, with an impressive upfront payment of $500M - I guess J. Michael Pearson also got a little hot and bothered over Addyi™ ! Personally, I think it's overpriced at that level, given that Sprout estimated annual peak sales at ~$100M, and I see sales dropping off sharply after the first year or two, with women who feel minimal benefit and who miss their glass of wine at dinner. It would have been "cheap at half the price", as we say in Ireland!
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