Is Osphena the new female Viagra?

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 company 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.

Jennifer Gunter is an obstetrician-gynecologist and author of The Preemie Primer. She blogs at her self-titled site, Dr. Jen Gunter.

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  • drll

    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.

    • The Corrector

      The risk of developing simple hyperplasia (which is a LONG way from uterine cancer) with Osphena is 0.1% (1 out of 1000 which is not clinically relevant nor statistically significant). And that’s WITHOUT using progestin. Taking estrogen without progestin leads to a 24% rate of hyperplasia (2400x the risk with Osphena). Taking estrogen WITH progestin leads to a 1% rate of hyperplasia (10x the risk with Osphena). So, Osphena carries 1/10 the risk of hyperplasia than the very best that estrogen can offer. So, would you like to reevaluate your thoughts?

  • http://genericpills247.co.uk/ Phil Evermore

    The search for a drug to increase female libido barking up the wrong tree in my opinion. There’s such a thing as ‘female Viagra’ which is actually just Sidenafil (the ingredient of Viagra) repackaged in pink tablets. The results are inconclusive. The lack of women’s libido is largely a psychological issue rather than a physiological one so I’m not sure if any drugs are the answer, although they may help in some cases.

    • The Corrector

      Agree completely with you. Just to make it obvious however, Osphena is NOT being marketed as a libido drug.

  • The Corrector

    There is so much misinformation and
    misinterpretation in this blog entry it’s SCARY. I’ll start from the top and work my way down…

    The indication is for dyspareunia due to vaginal ATROPHY,
    not dryness. Although this medication does increase lubrication and was statistically superior to KY Jelly in dryness in the Bachmann trial, it also REVERSES ATROPHY as well and that is the indication.

    Ospemifene is not the only one that works on the vaginal tissue – it’s the only one that works CONSISTENTLY in a POSITIVE manner on the
    vaginal tissue. Tamoxifen works as an agonist (estrogen effects) at low doses and as an antagonist (anti-estrogen effects) at high doses. Your statement suggests the others have no activity in the vagina which is untrue.

    You stated that Osphena should only ever be used when the
    cause of painful sex is low estrogen.
    Physicians in the US are free to use most medications as they see fit
    based on their discretion. I do agree that the pill is not a “Jill of all trades for sexual difficulties”.

    Saying Osphena has a “lot” of drawbacks is DRASTICALLY
    overstating things. Let’s explore your bullet points.

    It will stimulate the lining of the uterus – this is true. Ospemifene is a “mild agonist” of the endometrial tissues. This means it has mild estrogen-like effects on the endometrium. Oral estrogen has a VERY STRONG effect on the endometrium and is relatively likely to lead to cancer if a progesterone is not used to counteract those effects. The
    risk of hyperplasia (a precursor to cancer that usually gives signs such as bleeding which usually allows for early diagnosis and effective treatment) when using oral estrogen WITH a progesterone is 1%.
    The risk of hyperplasia with Osphena is 1/10 of that (0.1%) and that is
    WITHOUT using progesterone. In fact, Osphena has not been studied with the use of progesterone so it’s completely unknown what would happen if the two are used together. So, while it does stimulate the lining of the uterus, there is a one-tenth of one percent chance that it will lead to SIMPLE hyperplasia (which although relevant, is NOT serious). Additionally, the FDA has stated that vaginal estrogens should be prescribed with progesterone as well. That’s where the FDA took the wording for Osphena – from the vaginal estrogens.

    An increased risk of blood clots – the risk is there as it is there with ALL S.E.R.M.’s, but in the clinical trials, the clotting risk was no different than placebo.

    Hot flashes – this occurred in less than 1 in 20 patients when compared to placebo. Less than 1% of patients dropped out of the study due to hot flashes (or any other side effect).

    Drug interactions – you are correct about the metabolization of ospemifene, the only common drug that may be used while a
    patient is on Osphena is “fluconazole” – a drug used for vaginal
    infections. The interaction there is that fluconazole may increase the exposure to Osphena which may increase the side effect profile for Osphena. However, fluconazole is USUALLY a one-dose medication so in real practice, this interaction is not of any major significance.
    For patients on a longer regimen of fluconazole, Osphena can be
    discontinued and reinitiated once the infection has cleared and the treatment regimen has stopped.

    Vaginal estrogen therapy IS the standard of care and it has been for many many years because the only other option was oral estrogen
    therapy which many patients preferred to avoid for perceived safety risks. Osphena is a NEW option and therefore has not had the time to become a new standard of care.

    Vaginal estrogen therapy IS absorbed to a significant degree. Significant enough for the number one side effect across the board to be breast pain and tenderness. If a vaginally applied estrogen isn’t
    systemically absorbed, how is it causing pain in the breast tissue? Osphena IS NOT ESTROGEN and does not alter the amount of estrogen in the body.

    Vaginal estrogens have the EXACT SAME WARNINGS (rubber
    stamped from the FDA) as Osphena EXCEPT that they also have a warning for “Probable Dementia” which Osphena does NOT have.
    Those warnings are for endometrial cancer, breast cancer, and
    cardiovascular disorders.

    You are correct in saying that Osphena has been around only a short amount of time and therefore the long term use is unknown –
    however the FDA did not require Shionogi to do ANY additional studies on the medication and the FDA approved Osphena on the originally scheduled date. Either of those two occurrences are rare – both happening together are EXTREMELY rare. The FDA feels VERY good about this drug and the data behind it.

    You are also correct stating that Osphena hasn’t been studied head to head with vaginal estrogens. Similarly, the vaginal estrogens haven’t been studied head to head against each other. What’s your point? Also, how are you coming to the conclusion that vaginal estrogens have the fewest systemic effects? Is it by the number of warnings in the Package Insert for these products (vaginal estrogens have more than Osphena) or for the number of side effects (vaginal estrogens have more than Osphena) listed? Osphena has 5 listed adverse events at a rate of 1% or higher: Hot flush at 4.9% is the highest vs placebo. Vaginal/genital discharge (excess lubrication and a sign of a healthy vagina) is a side effect but from a clinicians standpoint – desired as it’s an indicator that the dryness and atrophy has been
    reversed and things are working as they should, muscle spasms/cramping (3 out of 100 people) and sweating (1 out of 100 people). Meanwhile, the list of side effects for vaginal estrogens can fill a page.

    Here’s your scenario where Osphena would be the first line treatment… A woman doesn’t want to stick a messy estrogen (often, a VERY uncertain dose) up her vagina and have it leak out and would prefer to swallow a small pill instead. A woman who doesn’t want to add estrogen to her body. A woman who doesn’t want to have to think about when she last took her vaginal estrogen, how that might impact her sex life, her partner, etc. A doctor who can’t rely on their patients to apply the correct amount of vaginal estrogen (because patients almost NEVER take anything like they’re supposed to and measuring out a cream and applying it EXACTLY as it’s supposed to falls into that category). Those sound like great scenarios for using Osphena to me.

    • Lily J

      Thank you very much for that information. As a previous GYN nurse, I know that many women CANNOT use estrogen creams because they can be irritating. In fact, the more atrophic their tissues become, the more irritating estrogen cream (and even lubricant creams) becomes. It also causes cramping in some women.

      This medication may be a God-send for women who still want to enjoy sex in menopause and have lost quality of life because they can’t use any creams. Perhaps the use of Osphena can get the tissues to the point where creams are an option – but in the meantime, I think there are plenty of women who will be grateful for this medication. They aren’t looking for an increase in libido – just a way to have non-painful sex.
      So, Holyhormones may be lucky in that she can use the creams – but for the women who cannot, I am hoping this pill can be a life-changer. Maybe it will BECOME the first line for women like these.

  • Holyhormones

    I do not understand why a drug is needed for vaginal dryness/atrophy when bioidentical estriol (weakest of the three estrogens) seems to work for nearly all women who use it. I have the cream (prescription) compounded, use it every other night, and it is safe and effective. Also, using a vaginal cream rather than a pill for a vaginal issue just makes more sense, with far less systematic side effects. It is my understanding that even when a cream is used, too often it’s a synthetic hormone (don’t get me started on that). I am blessed to have a physician who “gets it” and believes that replacing bioidentically the hormones lost as a woman reaches peri/menopause is far preferable to filling patients up with pharmaceuticals.

    • Lily J

      It’s great if it works for you, but many women in menopause cannot use the creams because their tissues have become SO atrophic that creams are irritating. You did say the creams work for “nearly all women” but there are those that cannot tolerate them. I am a previous GYN nurse and I know from that experience that women who cannot use any vaginal topical have lost some life-quality, and that is heartbreaking. I hope that this pill can be an answer for a few of those – sure, most people would rather use a cream than take a pill – but some just cannot.
      In fact, as The Corrector says in his response to you, that this medication actually reverses atrophy might just get these women to the point where creams ARE an alternative.

  • Lily J

    Osphena isn’t intended to be a female Viagra, it’s for vaginal atrophy! Two very different issues. Women who have a genuine need for a medication like this aren’t looking to increase libido – in fact, libido isn’t necessarily the problem. Women who have a need for this medication are menopausal either by age or hysterectomy, can’t or don’t want to use creams, and experience a great deal of pain with sex and after sex. I think it’s wonderful that a medication like this has come out.