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The reasons this GYNO is unlikely to prescribe Addyi

thAddyi (flibanserin), the drug to increase female libido had a timid entry into the market with very few prescriptions considering the “hype.” Bloomberg Business reported 227 prescriptions in the first month. That’s a pittance considering Valeant paid $1 billion for the drug.

I am unlikely to help Valeant recoup their investment, because the more I read about this drug the worse it looks. Here’s why:

It barely works

One of the study end points (meaning what you hope the drug will do) is increasing the feeling of desire. How Sprout measured desire is very controversial, but regardless even with their special scale that makes it practically pathologic to not feel desirous every waking hour only 10-13% of women (adjusted for placebo) had a significant increase in desire. So for every 7-10 women who take the drug, one will have a bump in desire (a measured by a scale designed for this drug). What about having more sex, the other end point in the studies? Only 8-9% of women has an increase in “sexually satisfying events” when you account for placebo.

Side effects. Lots of them.

21% of women taking the drug had significant side effects versus 8% for placebo. That means the placebo-adjusted rated of side effects is 13%. The placebo adjusted rate of having more satisfying sex is 8-9%, so a woman is more likely to have a side effect than she is to have more sex. In my mind this should exclude a drug from being approved. As the placebo adjusted “desire” increase is 10-13% at best Addyi will make women sick and slightly more horny in equal numbers.

No alcohol. Ever. At all.

I’ve written how the alcohol interaction was studied primarily in men. The alcohol safety data includes 21 men and 2 women. Sprout claims they couldn’t find more than 2 women willing to have the equivalent of two 5 ounce glasses of wine so they could properly study the drug’s effect. Makes you wonder if they didn’t want to know? When flibanserin was taken on the same day as the equivalent of 2 glasses of wine 4 of 23 people needed medical attention because their had such a profound drop in blood pressure or fainted. That is a very serious risk and as women metabolize alcohol differently there is a greater concern for women. This is a daily medication so no alcohol. Ever.

The burden of making sure the patient doesn’t drink alcohol is on me

The REMS (the joke of a power point presentation that Sprout calls safety training can be summarized as making sure the patient will never drink alcohol is your responsibility doctor, have fun with that in court! There is no way to guarantee someone won’t drink even if they do sign a form. I’ve been practicing medicine long enough to know patients say many things and often do the opposite. Sometimes they don’t really want to accept what you tell them, sometimes they don’t believe you, and sometimes life happens and they forget.

Drug interactions. Serious one. With two medications commonly prescribed for women

A woman taking Addyi can NEVER have a Diflucan (fluconazole, the oral medication for a yeast infection). At all. Ever. The interaction is so potent and potentially dangerous that you can not take a Diflucan within 2 days of starting the drug and within 2 weeks of finishing it (the Addyi has to be well out of your system). Oral contraceptives also may increase the risk of low blood pressure and fainting. Antidepressants may also increase the risk of side effects.

Animal study raises concern about a breast cancer risk

In a 2 year study of rodents there was an increase in cancerous mammary (breast) tumors in female animals but not male. This doesn’t mean that it will cause cancer in women, but it means than we need more studies. Some drugs cause cancer in one mammal, but not in others. That doesn’t mean the drug is abandoned, but in my mind it means the drug needs more study before it is unleashed as part of a campaign aimed at telling women they are being taken advantage of by the FDA when the drug didn’t previously get approved.

Cost

It’s $780 for a one months supply for a medication that one can only say has marginal efficacy if one is being generous.

 

Knowing all that I think it’s pretty easy to see why I’m not enthusiastic about the drug. Marginal, if any effect, Side effects. Drug Interactions. No alcohol. Unresolved question about cancer. It’s $780 a month.

If your doctor is excessively enthusiastic about Addyi and calls it “safe and effective” I would ask if they have received any money from Sprout, because it seems several of those who are openly vocal about its awesomeness have.

Meanwhile I wonder considering it takes 2 months to know if Addyi will work if people spent $1620 on a weekend away with their partner every other month or half the money on babysitters and half on fabulous dinners or would there be two extra sexual encounters in those two months while retaining the ability to have a glass of wine?

 

 

 

 

Discussion

8 thoughts on “The reasons this GYNO is unlikely to prescribe Addyi

  1. What really gets me is the drug interactions: “Oral contraceptives also may increase the risk of low blood pressure and fainting. Antidepressants may also increase the risk of side effects.”

    Since both oral contraceptives and antidepressants can affect your sex drive, people taking one or both of these types of medication might have low desire and might consider Addyi. But with an increased risk of side effects on top of its dicey effectiveness, I’m guessing it won’t be worth it to most people. So this drug is pretty much useless to the people who could benefit the most from a medication that could increase their sex drive.

    Posted by Ashley Casey | November 18, 2015, 6:50 pm
  2. It seems like we need more research into the affects of marijuana on libido and pleasure. That seems to hold more promise.

    Posted by Melanie McNeil | November 18, 2015, 7:17 pm
  3. Cut to the future, when the “problem” this medication seeks to solve still exists and all the blame is put on the women taking it.

    Posted by SoRefined | November 18, 2015, 9:36 pm
  4. I agree with your last paragraph about investing in time with each other instead of in a medication. However, those who feel pushed to the max for time I feel might think its more convenient to take a pill than put the energy into doing something with their partner.

    And the marijuana thing is serious. Ive read some very interesting articles about it. Plus you can share a bag of doritos with your partner and lick cheese off their lips. Sounds perfect!

    *** Disclaimer: Doritos did not pay me for this endorsement.😉

    Posted by thescarlettside | November 19, 2015, 9:14 am
  5. While I agree with most of your gripes I don’t think the ratio of side effects to useful effect is not a reason to say it’s unacceptable. If it doesn’t work for a woman she will stop taking it. Thus most doses will be taken by women for which it does work. A drug that only works for a small percentage of the population is one for each patient to evaluate whether they want to try it, it’s not evidence that it shouldn’t be on the market.

    Posted by Loren Pechtel | November 19, 2015, 9:18 am
  6. I will never prescribe this drug because of all of the reasons that Dr. Gunter listed above. Fortunately, I work at a Community Health Center that is integrated with behavioral health counselors and we can apply a holistic approach to the problem without the expensive poison sold by Sprout Pharmaceuticals.

    Posted by William stueve | November 19, 2015, 1:11 pm
  7. I can’t help thinking that things like men treating women like actual people, caring about whether women enjoy sex, and not expecting women to behave and look like porn stars would have all (or more) of the efficacy of this drug without the side-effects…

    Posted by jodiethalegend | November 21, 2015, 7:39 pm
  8. It makes me very angry. It feels like a drug company taking the piss. Had Viagra been this problematic, it would never have gotten approval. But more, drug companies KNOW men would have never tolerated this kind of pathetic efficacy rate and ridiculous contraindications. They wouldn’t have bothered with it.

    Posted by Remittance Girl | November 22, 2015, 4:53 am

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