Flibanserin is poised for FDA approval. But why this drug? And why now?
Women with hypoactive sexual desire disorder have long sought a remedy for this common complaint. With an advisory committee recommending approval of flibanserin, their wait may be over.
Why now?
As I stated earlier, a failure to approve flibanserin would set a dangerous precedent. Why? Because the company did everything the FDA asked it to do, and the results came out statistically significantly better than placebo—which was the desired endpoint. If the FDA were to deny approval of the drug, it would be saying, in effect, that it can change its mind in the middle of the argument—something it faulted Boehringer Ingelheim for in earlier deliberations (switching the insensitive electronic diary for the statistically significant FSFI).
In reality, the FDA is likely to say yes to approval, but with restrictions, as that is what its advisory committee recommended. What those restrictions will be remains to be determined, but they are likely to resemble those of other drugs in the class, such as selective serotonin reuptake inhibitors (SSRIs), including a warning to be careful using flibanserin with alcohol until the drug’s effects are clear.
Opposition to flibanserin misses the mark
During the public hearing portion of the advisory committee meeting, most of the testimony came from women seeking approval of the drug. However, there were some naysayers. Their arguments against approval boiled down to 4 perspectives:
- the view that development of flibanserin represents “medicalization” of a disorder that can be treated effectively with psychotherapy and education. This perspective is best embodied by an organization called the New View Campaign. Refuting this perspective, however, is research in animal models that clearly demonstrates that HSDD (or its equivalent in animals) is the result of an imbalance between dopamine and norepinephrine on the positive end and serotonin on the negative end. These findings are supported by functional magnetic resonance imaging (MRI) and positron emission tomography (PET) scans of the brains of women with HSDD who are shown erotic stimuli.8,9 The scans demonstrate that their brains respond differently from those of normal women. So if it’s all about education and counseling, why are the brains of women with HSDD functioning differently? I would argue that, if depression and HSDD are both abnormalities of the serotonergic system (flibanserin is essentially an SSRI), then how can depression be a biologically based disorder but HSDD can’t? In my opinion, the New View Campaign isn’t new at all.
- the view, represented by an organization called PharmedOUT, that marketing by pharmaceutical companies overly influences prescribers, ultimately medicalizing problems that don’t require medication or overselling medications for problems that may require drug treatment for a short time only. This organization is headed by an academic physician who has not seen patients in many years and has never treated women for HSDD.
- the view, represented by the Public Citizen Health Research Group, that the safety profile of flibanserin is lacking. This organization argues not just against flibanserin but against pretty much any drug. In its view, there are never enough safety data. I would argue that, when it comes to flibanserin, there are more safety and efficacy data than there are for almost any other women’s health drug. Most drug companies test their medications in 1,500 to 2,000 people, as the FDA requires. Sprout Pharmaceuticals tested flibanserin in almost 8,000 women. The total number of individuals who have been studied, in fact, exceeds 11,000.
- the view, represented by the National Women’s Health Network, that the drug’s risks outweigh its modest benefits. As I have pointed out, however, the benefits of flibanserin have been downplayed in data analysis, and the body of safety data for the drug is substantial.
There is also the sociological view that HSDD is a normal variant of healthy sexual function. Its adherents argue that women with HSDD feel distress because their male partners are forcing them to feel inadequate. But I have yet to hear a single critical voice from a physician who actually treats women and who can prescribe drugs. The opposition to flibanserin, such as it is, flows from people who don’t see patients and can’t prescribe medications.
These naysayers are negative in a theoretical vacuum. It’s very easy to fall into that trap when you don’t have to look across the consultation desk to a patient who is asking you for a remedy—a woman who’s been suffering for 25 years, say—and have to tell her you have nothing to offer. You might mention testosterone, explaining that it was approved for men but you’ll try to prescribe an appropriate dose. But be sure to include discussion of its many side effects.
