NIR has not covered the journey of flibanserin/Addyi , but we have watched with interest, and as the FDA decision loomed, we fielded a couple of calls from print journalists inquiring about our views on this somewhat controversial drug for female sexual desire disorder. Yesterday’s FDA approval was followed by today’s billion-dollar acquisition of Addyi by Valeant, and a comment is in order, since the very essence of the Addyi premise is that to a large degree, this is a ‘brain-based disorder’, as opposed to male sexual dysfunction, which is largely, albeit not entirely, an issue of hydraulics.
Addyi is a mediocre drug with a minuscule therapeutic effect, one that provides a minimal level of improved sexual functioning to a small minority of women trying it. It has some problematic side effect issues. But we do believe that it was the correct decision to approve Addyi, now the first and only drug tested, approved, and labeled for a condition which is estimated to affect sixteen million women in the US alone. Part of this is a gender politics quandary; in an environment where drugs for male sexual dysfunction have become a part of the popular lexicon, purchased (and covered by insurors) to the tune of many billions of dollars per year, and couples in hot tubs gazing at the horizon have become a routine backdrop for televised sporting events, we would not want to be the regulatory agency saying no to the attempt to develop something of a parallel for women. Frankly, to say no to the offering of an option would have been an exercise in condescending paternalism, and this is the last area where paternalism should show its face. It is a domain where women and their physicians should be able to make informed decisions.
After all, this is a domain that is poorly understood, and neural chemistry is just one factor amongst a host of others, including the hormonal and interpersonal, that mediate a woman’s level of sexual desire. There is no way for a single compound to provide a panacea for something that is so highly interwoven with the context of a relationship. In fact, it may matter little just how much actual pharmacologic impact this drug has, vis-a-vis how much is based on expectancy, and the inevitable placebo effect: Just the contemplation of whether or not to try Addyi will have a reverberating effect within a couple’s relationship, and indeed, couples therapists should have field day contending with couples wrestling with the decision to try–or not to try–a pharmacotherapeutic intervention. It brings their sexual relationship, and the role of women’s desire, to the forefront, and if the effect is to foster more sexual intimacy, that has the potential to be self-reinforcing. To that degree, even more than in so many disorders, this will harness the placebo effect in a way that could be more durable than it usually is. Of course, if it is the relationship itself that is the primary source of dysfunction, then a drug intervention will fail, sooner rather than later.
This brings us to Valeant Pharmaceuticals. We despise Valeant, a company that routinely treats acquired companies like poachers who have machine-gunned an elephant in the veldt, stripping the tusks while leaving the carcass to rot in the tropical heat. But in this case, there is nothing else, no R&D operation to be trashed; Sprout Pharmaceuticals is a one-product gamble that has paid off very well for the entrepreneurs who acquired flibanserin after Boehringer Ingelheim dropped it. We are somewhat stunned at the billion dollars to be paid upfront (even if in two installments); with the uncertainties attached to Addyi, we expected a deal that included more in the way of sales milestones. It is possible, that if initial word-of-mouth is negative, or if insurors resist the (initially cited) $5000 per year price tag (they will rue the day, if they reimburse ED drugs more liberally), that Addyi will end up only a minor success. But if just 1% of the projected, potential patient population in the US uses Addyi for six months in a year, that would produce gross revenue in the $400 million range (we are not going to spend time projecting rebates and the like). Addyi is not going to be a product to rival the Viagra and Cialis franchises, it costs too much and provides too little, but it is likely to be remunerative for Valeant. We only wish we could be a fly on the wall of the advertising agency brought in the develop the eventual OTC marketing campaign for Addyi, which is going to have to walk a tightrope of nuance as they navigate this marketing minefield.