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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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June 21, 2010

Flibanserin: Not a "Female Viagra" At All

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Posted by Derek

I haven't commented on the controversy over Boehringer Ingleheim's drug for female libido, flibanserin. An FDA advisory panel voted it down on Friday, and it wasn't close: 10-1 against whether the drug showed efficacy, and unanimously against its side effect profile. I really don't see how the drug is going to make it back from that kind of reception.

The press coverage of this compound has not been good. Far too many headlines have called it "Female Viagra", which is ridiculously off-base. Viagra, for its part, does absolutely nothing for the libido; it's plumbing, a pure cardiovascular effect. The assumption (a reasonable one, for many men) is that the desire is already there. Meanwhile, flibanserin is a central nervous system agent, affecting the mental state of sexual satisfaction, not any cardiovascular sequelae. The drugs are completely different.

And the FDA panel's problem (one of their problems) with the drug was that it doesn't seem to do much for desire, either. We can argue all day about whether low desire is a disease or not, but even if someone does want to do something about it, flibanserin doesn't seem to be the answer.

Boehringer is taking a lot of criticism for bringing the drug this far, actually. It was originally developed as an antidepressant, but during the trials reports came in of the sexual effects in female patients, so they repurposed it - taking the drug out of a crowded field and into completely new territory. You can admire that as showing flexibility, or you can worry that the company found a possible drug and then went shopping for a disease, with a willingness to invent one if it didn't quite exist.

I don't know where I stand on that latter point; I've no idea what the statistics are on low sexual desire as a problem (and I'm willing to bet that what numbers might exist have whopping error bars on them). But I think that we're not going to be revisiting this topic any time soon. The FDA panel officially encouraged Boehringer to continue research, but the vote tallies are not the sort of thing that would encourage anyone.

Comments (25) + TrackBacks (0) | Category: Drug Development | Regulatory Affairs | The Central Nervous System


COMMENTS

1. Virgil on June 21, 2010 8:26 AM writes...

Restless legs syndrome?
Dry mouth syndrome?
Social anxiety disorder?

With apologies in advance to anyone who thinks they have such a condition, did these conditions exist before big-pharma made them up, to sell their orphan drugs?

The bigger story here, is the knock on effect this ruling will have on the small pharma companies trying to get into this marketplace. Their share prices are surely going to be lower today.

Permalink to Comment

2. Josh on June 21, 2010 8:59 AM writes...

Dry mouth is an actual condition (also known as xerostomia), usually a by-product from Sjogrens or chemo.

A lot of the conditions have been around, just never had a name or treatment. For instance, HSDD has been around for 30 years....people just haven't worked too much on treatments.

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3. partial agonist on June 21, 2010 10:16 AM writes...

"Social anxiety disorder" is not some made-up condition. I have first-hand (admittedly anecdotal) experience of a someone close to me who suffered from this and was completely non-functional in settings outside of the home. That was, until dosing with an SSRI changed everything and permitted a life that was normal in every way. After a year or so of dosing with fluoxetine, the drug was weaned away with great success-- an apparent permanent "rewiring" of the brain had occurred, when other therapies had failed.

CNS drugs are tough things to appreciate until you see them work. It is normal to have a "get over it" attitude until you have some first-hand experience.

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4. Rob on June 21, 2010 10:25 AM writes...

Since lack of interest in sex, and for that matter almost anything else, is a symptom of depression the initial results aren't exactly surprising. Increasing interest in life's activities is exactly what an anti-depressant "should" do. What is upsetting is that they took the results out of a clinical context (helping with a relatively specific problem) and tried to transfer it to the general public.

Permalink to Comment

5. Cloud on June 21, 2010 10:28 AM writes...

Huh. My take, based on the totally unscientific method of reading mommyblogs and the like is that low desire IS a problem for a lot of women. But I suspect the solution is pretty low tech- more sleep, some time away from the kids, etc. And then there's the hormonal factor. Low desire is an actual side effect of some hormonal birth control methods. Which makes them very effective, I suppose. This isn't too surprising- I suspect that for most of human history, low desire was a bit of an advantage when you had a baby to care for.

Which is not to say that there aren't some women out there with an actual chemical imbalance that might be classified as a disorder. But those women are probably a much smaller market.

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6. processchemist on June 21, 2010 10:38 AM writes...


As far as I know there's someone with projects of this kind still alive.
Love potions and Long Life elixirs seem to have quite a grip on investors...

Permalink to Comment

7. anomonous on June 21, 2010 10:40 AM writes...

The other name for a chemical imbalance is menopause. No hormones leads to no sex drive. Enjoy it while you got it, kids.

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8. g on June 21, 2010 12:23 PM writes...

The trial had multiple endpoints- 1) increasing sexual desire and 2) increasing the number of sexually satisfying events. It only failed in reaching the first endpoint.

Viagra has been beneficial for male sexuality/desire for the fact that an inability to acheive an erection definitely makes a man not want sex as much. However, desire goes up when there is an erection. For women, increasing the satisfaction of the sexual event may well increase desire in the long run.

I expect that we'll hear from this drug again.

#3-so true. Mental illness can be crippling.

#4-most antidepressants will suppress sex drive even while improving mood (possibly not wellbutrin through)

#7-all the women in the study were premenopausal

Permalink to Comment

9. MoD on June 21, 2010 2:00 PM writes...

It's a shame the money and time spent on this BS was not better used on life threatening diseases.

Permalink to Comment

10. medicamenta vera on June 21, 2010 3:16 PM writes...

I worked for BI until I was encouraged to seek other opportuniites last year.

When asked, the clinical folks never made it clear how Flibanserin was going to be marketed. This isn't their job, but I expected that the clinical strategy would be predicated with the endgame in mind.

Cloud, I believe you are right on target regarding de-stressing and libido. I haven't cruised the mommblogs, but I've always thought that the main customers would be husbands who would spray flibanserin around the house or slip it into their wife's favorite skin moisturizer.

Virgil, I have restless leg, falling asleep can be a b____h sometimes. Yoga has helped. If I had used Mirapex I might have gambled asay the huge 3 weeks of pay BI gave me when they showed me to the parking lot.

Permalink to Comment

11. John on June 21, 2010 3:24 PM writes...

I've heard a lot of comments over the years on how it was immoral to spend R&D money developing Viagra, when there are so many life threatening diseases for which there is no good treatment. What cracks me up is how much of this criticism comes from people who rave about the latest tech gadgets, such as those from Apple, which spends $1.3B per year developing better cell phones.

Having a robust sex life or a touch screen on my cell phone? Hmm, how to choose?

Permalink to Comment

12. p on June 21, 2010 3:39 PM writes...

Most of the diseases that critics like to question are, in fact, real diseases. It's just that you can have similar symptoms simply by living. So, yes, there is a dry mouth syndrome that is crippling. There are a lot more people who are just a little dehydrated. However, the latter people can be convinced, through clever marketing, that they need a pill and, voila, the next big drug is born.

Permalink to Comment

13. AndrewT on June 21, 2010 5:10 PM writes...

I'm curious about what the FDA's going to decide with Bremelanotide (PT-141) from Palatin Technologies.

Permalink to Comment

14. alig on June 21, 2010 7:59 PM writes...

Wellbutrin, the Happy Horny Housewife pill.

Permalink to Comment

15. anon on June 21, 2010 11:32 PM writes...

"Having a robust sex life or a touch screen on my cell phone? Hmm, how to choose?"

I've heard iPhones are a "chick magnet".

BTW: AAPL easily recouped its iPhone development costs. It helps that there's no FDA for cell phones-- closest is the FCC and they haven't discovered the phrase "can you repeat your phase II study" yet.

Permalink to Comment

16. Morten G on June 22, 2010 1:19 AM writes...

"I've heard iPhones are a "chick magnet"."
And if that doesn't work you could always just whack them over the head with your iPad.

But back to Flibanserin. Wouldn't you rather have one of these slipped in your drink by some loser than a roofie? Then again I haven't ever heard off any guys getting Viagra slipped in their drinks so...

Permalink to Comment

17. A Nonny Mouse on June 22, 2010 5:49 AM writes...

#14

Too true! See the Wikipaedia write-up. I must confess we had a lot of anecdotal stories on the effect on males when it was going through trials, but we never heard much about the female side of things.

Permalink to Comment

18. Vader on June 22, 2010 9:53 AM writes...

So this drug is essentially an aphrodisiac?

I guess we do need a less toxic substitute for Spanish fly.

Permalink to Comment

19. Lu on June 22, 2010 11:28 AM writes...

I think there is no "low desire" problem. There is a problem of desire mismatch between partners.
While a pharma company happily made a pill to increase desire in women the mere idea of lowering men's desire would have violent opposition.

So much for equality of sexes...

Permalink to Comment

20. LeeH on June 22, 2010 4:06 PM writes...

#11

Pfizer didn't spend any money developing Viagra as an ED drug. It was an anti-angina agent, and the ED "side effects" were only identified when the compound went into man.

Permalink to Comment

21. fred on June 22, 2010 9:24 PM writes...

"While a pharma company happily made a pill to increase desire in women the mere idea of lowering men's desire would have violent opposition."

Keep an eye on your drinks when you put them down, guys!

Permalink to Comment

22. doctorpat on June 25, 2010 8:20 AM writes...

"While a pharma company happily made a pill to increase desire in women the mere idea of lowering men's desire would have violent opposition.

So much for equality of sexes..."

I may be missing the point, but I'm fairly sure that a drug to reduce women's desires would also have violent opposition.

It's not an equality thing, it's a "more sex is better, less is worse" thing.

Permalink to Comment

23. HealthMarry on June 29, 2010 12:45 PM writes...

The best drug for female arousal is to see a man wash dishes/clothes, mop a floor, cut some grass, play/raise the kids, work hard, pay the bills on time and be kind with his words and go to church every once and while....my goodness imagine the intimacy if you arent concerned with infidelity, lying and unemployment....oh that feels sooooooo goood.....yes! yes! yes! Now that will make any woman slobber on the pillow. Thank you Big Daddy! See, can't get all that in a PILL!!!!

Permalink to Comment

24. HealthMarry on June 29, 2010 12:46 PM writes...

The best drug for female arousal is to see a man wash dishes/clothes, mop a floor, cut some grass, play/raise the kids, work hard, pay the bills on time and be kind with his words and go to church every once and while....my goodness imagine the intimacy if you arent concerned with infidelity, lying and unemployment....oh that feels sooooooo goood.....yes! yes! yes! Now that will make any woman slobber on the pillow. Thank you Big Daddy! See, can't get all that in a PILL!!!!

Permalink to Comment

25. Hyman Donnick on August 18, 2012 9:58 AM writes...

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