Addyi Passed by FDA; Will it Help Low Libido?

This past August, the Food and Drug Administration (FDA) approved the first prescription drug designed to increase women’s sexual drive. Addyi (rhymes with Daddy, don’t ask me how they come up with these names), developed by Sprout Pharmaceuticals, has been dubbed the “Female Viagra.” However, unlike Viagra used primarily by men to help them with their erections and other PDE5 inhibitors which allow more blood flow to a penis, this medication works on the brain. Another important difference is that Viagra (and the medications for a man’s Erectile Dysfunction) is taken as needed and works pretty rapidly whereas Addyi is taken every day, much like an anti-depressant and one may not see improvement until 4 weeks have passed.

Addyi is being hailed as the first of its kind to treat the root of the issue formerly known as Hypo Sexual Desire Disorder (or HSDD), now called Female Sexual Interest/Arousal Disorder (FSIAD) in the new DSM 5 (Diagnostic and Statistical Manual)
in pre-menopausal women. The new DSM 5 merged the experience of not feeling frisky or interested with the experience of not being able to get physically aroused.
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HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner. (www.fda.gov)

Originally developed as an antidepressant, Addyi works on the neurotransmitters in the brain to increase desire. While it is without question that the FDA and pharmaceutical companies often discriminate towards women in drug development and manufacturing, before women across the United States can truly claim victory, there remain strong concerns that this miracle pill (dubbed the little pink pill as a marketing ploy to resonate with the little blue pill that is Viagra) might actually bring more harm than good.
pinkpill One of the biggest concerns surrounding Addyi is whether the drug actually does what it claims. Approval for Addyi (when it was called Flibanserin) was actually previously rejected by the FDA twice – in 2010 and 2013 – for many reasons, including lack of effectiveness.

Even in the most recent studies, women taking Addyi only saw just one more sexually satisfying event (SSE) per month than those participants just taking the placebo. What my clients come in discussing is the loss of their intrinsic desire (or what some would call horniness, a physical tingling that alert them to their desire, an erotic fantasy or awareness that one is turned on) versus receptive desire (prompted by flirting, a fun date, or an intimate connection for example). Some in my field are not clear whether the Addyi study really were able to tell the difference in these types of issues by looking mainly at SSEs.

Moreover, many women do not realize the power their erotic mind has in boosting their drive and they do not understand that intrinsic physiologic triggers wear off naturally over time – which is why many in my field are asking whether we know enough about women’s desire to a) called it a medical pathology in the first place and b) offer them a medication versus educating women on other ways to increase their desire through other means? Considering that there was a high placebo effect in the study confirms my belief that some women need more education on how to enhance their erotic triggers besides intrinsic biological triggers.

In addition to the minimal evidence that the medication provides any substantial benefit to a woman’s sexual desire, I also share others concerns surrounding the side effects of this medication. As I mentioned above, the FDA previously rejected Addyi and another reason for those rejections were due to the high risk of side effects. First, there are the common side effects which including fainting, drowsiness, nausea, dizziness, and low blood pressure. While these are common for many other medications, women taking Addyi are also heavily counselled to abstain entirely from alcohol while on this medication because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol.

The FDA felt so strongly about these side effects that each Addyi box will contain strong labeling highlighting these risks. Moreover, any doctor wishing to prescribe Addyi and any pharmacist that sells this medication must complete an online training course. It seems unrealistic to ask women – who may use alcohol as a means to relax prior to a sexual encounter – to abstain from alcohol and experience strong side effects from a pill that might only minimally increase their sexual arousal.

Finally, it also remains unclear that insurance companies will even cover Addyi. Some argue it would be equivalent to a monthly dose of traditional Viagra which is approximately $400, not an affordable medication for most folks. This means that even for a patient who does experience increased libido with no side effects, cost might continue to be a barrier. But pharmaceuticals are big business and when Sprout Pharmaceuticals was acquired by Valeant for $1 billion dollars, it was clear they were investing for a huge long-term gain on investment. You have probably heard about Valeant as recently as this past week, since it has reportedly raised the price on its brand name medications an average of 66% this past year.

While I am hopeful now that the FDA are taking women’s medical issues more seriously, and that they are interested in helping women who indeed have HSDD, I think we have to help women strengthen their Sex Esteem® by
a) figuring out if their low desire fits the criteria for the diagnosis of FSIAD
b) continuing to educate women on the many-layered causes for lower desire over long-term relationships
c) help them make an educated decision whether they need a medication.
d) ensure that they aren’t going to use alcohol when on the medication.

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