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painful sex, sex

Is Osphena the new wonder drug for better sex?

Osphena (ospemifene) is an oral medication recently approved by the FDA for painful sex (dyspareunia) due to vaginal dryness for menopausal women. As typically happens when a new drug gets FDA approval the PR machine for the companyScreen shot 2013-07-31 at 11.32.13 PM goes into overdrive flooding the media with press releases. Since sex sells, well, Osphena received a fair amount of air time and print space. Headlines like FDA-Approved “Female” Viagra might lead someone to believe that Osphena is freaking amazing. Which, of course, it is not.

What is Osphena? It is an estrogen agonist/antagonist, meaning on some tissues it acts like an estrogen and on other tissues it acts like an anti-estrogen. It acts like estrogen on the vaginal tissues and the lining of the uterus, but it acts like an anti-estrogen on the breast (note; this is in animal studies). There are 3 other drugs on the market in the same class (tamoxifen, toremifene, and raloxifene), however, ospemifene is the only one that works on vaginal tissue.

As estrogen levels drop during menopause (and sometimes a few years before) the vaginal tissues often become fragile and secretions decrease. The vagina may feel dry and sandpaper-like and the tissues may be unable to withstand the friction of intercourse even with a ton of lube. This discomfort is typically treated very effectively with topical estrogen (cream, vaginal tablet, or a ring) which increases secretions and improves the thickness and elasticity of the vaginal tissues. Many women who want to have sex after menopause will need vaginal estrogen, there is just no way around it.

But what about this new drug, Osphena?

First of all, Osphena should only ever be used when the cause of painful sex is low estrogen (the clinical term is atrophy). In other words, this pill is definitely not a Jill of all trades for sexual difficulties.

Secondly, Osphena has a lot of drawbacks and potential problems, many or which are very serious, including the following:

  • It will stimulate the lining of the uterus and if not prevented this could lead to cancer of the uterus. Women with a uterus will need to take an oral drug called progesterone or a progesterone like drug to prevent this cancer (although a Mirena IUD would also do this).
  • An increased risk of blood clots
  • Hot flashes as Osphena as like an antiestrogen on some tissues. Not everyone reports hot flashes, but it is definitely listed as an adverse effect.
  • Drug interactions. Osphena is metabolized by several liver enzymes that are responsible for the metabolism of other drugs. When two drugs use the same enzyme system side effects and serious adverse reactions are more common. On the flip side, this interaction can also cause a drug to be metabolized so quickly that it becomes less effective. A prescription for Osphena should prompt an review of your medications with a pharamcist.

Vaginal estrogen therapy is the standard of care for pain with sex due to menopausal changes. It is not absorbed to any significant degree and does not affect the lining of the uterus, increase the risk of blood clots, or have drug interactions. With vaginal estrogen women don’t have to take a second medication to prevent uterine cancer. Also, Osphena has not been around very long so there could be unknown long-term side effects. 

Osphena has never been studied head-to-head against vaginal estrogen, so while it may be better than placebo no one knows how it might perform against vaginal estrogen. Vaginal estrogen replacement for the majority of women will be the safest option with fewest systemic effects.

Is Osphena the new female Viagra? Not by a long shot. In fact, it seems to be a drug looking for an indication as it is hard to imagine a clinical scenario where Osphena would be the first line treatment for vaginal atrophy.

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Discussion

13 thoughts on “Is Osphena the new wonder drug for better sex?

  1. Neurocritic has written about how some “female viagra” drugs aren’t like viagra at all, because they enter the brain, which viagra does not. Does Osphena pass the blood-brain barrier?

    Posted by wileywitch | August 1, 2013, 12:41 pm
  2. I rather suspect it’s for women who are afraid of estrogen.

    Posted by Loren Pechtel | August 1, 2013, 2:56 pm
    • It probably is, but if you are afraid of estrogen you should be more afraid of a systemic drug that requires you take a 2nd systemic hormone to prevent cancer.

      Posted by Dr. Jen Gunter | August 1, 2013, 9:19 pm
      • Afraid of doesn’t mean the fear or it’s response is justified.

        Is there actually any medical case for this? I would think it would be contraindicated for anyone who has issues with estrogen and otherwise it sounds inferior to what’s already on the market.

        Posted by Loren Pechtel | August 2, 2013, 6:22 am
  3. BRAVO!! I agree 100%. I was paid $300 for my opinion (from a marketing research company) on this new oral remedy for vaginal dryness (I disdain the term ‘atrophy’) and I basically told them that there would be a very small subset of women who I would prescribe this medication.
    In terms of the ‘female viagra’ claim, this is ludicrous as female sexuality and response is very complicated. Vaginal dryness and dyspareunia is only one component.

    Posted by Janis L. Enzenbacher | August 2, 2013, 3:47 pm
    • You seem very un sympathetic to those of us who have suffered and I do mean SUFFERED, with painful intercourse, due to menopause. In my case it was due to a hysterectomy and vaginal Estrogens never helped. There was one idiot who wanted to send me to a psychiatrist but that was never my problem. It is cruel to let women suffer like this, and it ruins lives. Open your mind, for God’s sake.

      Posted by Kay Foley | January 24, 2014, 8:48 pm
    • I disagree! Speaking for the “subset of women” who are surviving estrogen related breast cancer, post hysterectomy, I am anguished that my loving partner and I have also lost the ability to have comfortable sex due to vaginal atrophy. This Osphena drug could be just what I need to be able to still experience a pain free sex life with my partner.
      It bothers me that so many comments I have read have been so dismissive of the very large “subset” that are in the same situation as myself, for which this treatment could add greatly to quality of survival.

      Posted by Brady | August 6, 2014, 10:31 am
      • Many women who are menopausal and had breast cancer do suffer from painful sex and it should never been discounted as insignificant. However, if you had estrogen related breast cancer then Osphena (given the current body of literature) is unfortunately not recommended. http://www.osphena.com/hcp/p/faqs

        Posted by Dr. Jen Gunter | August 12, 2014, 7:25 pm
  4. I wish that someone would take seriously the distress caused by the loss of libido that many women experience as they age. HRT only goes a small way to countering this, and vaginal estrogen only addresses the local problem of dryness. Damnit, I want to feel sexy again but the general attitude of the medical profession in my experience is to ask whether I’m really still interested in sex at my age (59).

    Posted by Kate Corwyn | August 3, 2013, 6:23 am
  5. Well first of all I want to congratulate Shionogi on their very catchy name of their new drug, Osphena. It sounds almost like the name of a greek goddess. No doubt there was a lot of money spent on generating that name.
    I used to actually trust the FDA. Unfortunately these days well lets think about this one. There is no proof that it works any better than the current standard treatments AND there could be a risk of cancer if a patient is non compliant. Of course the doctor would prescribe this giving the pt the progesterone like drug if the woman has a uterus but still how many pts might be noncompliant and forget to take it even with all the warnings. Is it worth the risk of getting uterine cancer?

    Hmmmmmmm…
    Great idea FDA and shenanigan -I mean Shionogi.

    Posted by laurie | August 15, 2013, 8:32 am
  6. After 12 weeks of using Osphena ….. It does ease the pain of intercourse somewhat …. However it has produced an annoying discharge , it is very costly and it very hard to get to the pills the way they are packaged. I’m not too sure I will continue with it .

    Posted by Kathryn | January 12, 2014, 5:34 pm
  7. I have been taking Osphena for over two months and I have to say it has worked for me. The moisture is back and even the desire. Husband has a big smile. I do not have a uterus so don’t worry about that side effect . The only down side is some nighttime hot flashes. I would say to do your own research and talk with your Doctor about trying this drug.

    Posted by JK | March 9, 2014, 4:12 pm

Trackbacks/Pingbacks

  1. Pingback: Causes of painful sex (dyspareunia) simplified in one image | Dr. Jen Gunter - August 20, 2013

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