New Pill? Viagra for Women!

lilpinkpil

You may have heard in recent news that the an FDA advisory committee is pushing for the approval of a new drug, Flibanserin, which is being hailed as “viagra for women,”  and decision by the FDA is expected on or before August 18, 2015. Many women suffer from a low sex drive for many different reasons.  I myself have suffered with one since my Lupron Depot injections, which were immediately followed by a continuous birth control.  My libido is nearly non-existent nowadays. Blah.

But what is this drug? What are the potential side effects? How long were the clinical trials?  All of these questions come running to the tip of my tongue – will the pros outweigh the cons?  Will there be interactions with my birth control pill?  Less questions, MORE RESEARCH!

Flibanserin

In 2006, Flibanserin was first tested and developed by a German pharmaceutical company, Boehringer, as an anti-depressant medication. The drug lowers serotonin while raising dopamine, and norepinephrine levels in a woman’s brain.  The initial anti-depressant trials of the drug with women showed an increase in sexual desire, which prompted new studies with thousands of women.  The hope was to pass it off as a libido-increasing drug to combat the affects of hypoactive sexual desire disorder (HSDD).  However, due to it’s failed attempts at FDA approval to treat HSDD, Boehringer sold the rights of the drug to Sprout Pharmaceuticals in 2011. Sprout Pharmaceuticals filed their patent in 2014.

Sprout Pharmaceuticals was developed in 2011, solely for the purpose of creating a libido-enhancing drug for women.  They have not produced any drugs on the market, to date.  However, several of their executive team hail from other pharmaceutical companies such as Slate Pharmacueticals (manufactured Testopel), Halozyme Therapeutics (manufactured Hylenex), Actient Pharmaceuticals (a company which acquires pharmaceutical companies), Hyman Phelps & McNamara (a food & drug law firm), and AAI Pharma (a pharmaceutical testing company).

The suggested dosage for women would be 100mg per day, likely taken at night.  For some women in the clinical trials, it took 4-8 weeks before they felt any improved sexual response.

There is a huge lobbying campaign by several women’s groups to approve this drug, stating that men have a lot of approved libido-enhancing drugs, where women have zero.  I see their point…but…safety first!  The National Women’s Health Network strongly opposed the drug’s approval at the recent hearing due to concerns over side effects.

Potential Side Effects

Since 2010, the FDA rejected Flibanserin’s approval due to concerns over the side effects, which may include dizziness, fainting, sleepiness, low blood pressure, and nausea.  Sprout Pharmaceuticals has tried twice since 2013 to have the FDA approve the drug, and failed.

Side effects may be worsened by prescription drugs (particularly, birth control pills) and/or alcohol.  There were also concerns expressed at the advisory committee hearing over a potential for increased accidents (trips, falls, vehicle collisions, etc.) due to these side effects.  Reportedly, one woman reacted so poorly in a clinical trial that she had to be hospitalized.

However, the advisory committee feels that with proper warnings and labels, this drug has the potential to change the lives of a lot of women, and their significant others.   They are also hoping a bona fide, approved drug will help steer women clear of unsafe internet wonders and snake oil treatments for lowered libidos.

Studies

There are countless reports and studies regarding Flibanserin available to you through the interwebs.  I will discuss a few here, but for a comprehensive list, please click here.

Sprout Pharmaceuticals ran a 24-week trial, and the results showed that the Flibanserin had positive effects for 46-60% of the women taking that pill; however, the advisory committee altered those numbers once they figured in the placebo pill.  After the committee’s alterations, they found only 10% of women had positive feedback; which was about an increase of one sexually satisfying event per month.  The advisory committee stated that the drug had “marginal to moderate” results.

There was also a two-year cancer study on the effects of raised dosages in mice, which found an increased risk of breast cancer tumors (these mice received four-times the recommended dosage).  There are reports that studies of Flibanserin lasted anywhere from one year to 18 months, and the FDA is concerned over the lack of time taken to evaluate any potential cancer risks.  Sprout Pharmaceuticals reminded the advisory committee that just because studies in lab animals shows an increased potential for developing breast cancer, doesn’t mean those study results will transfer over to humans…

What Now?

The advisory committee has begun preparing their recommendation package to be presented to the FDA to aid in their decision.  This will include suggested warning labels, educational materials, training for professionals who will prescribe this medication, etc.

Some members of the advisory committee who voted against the pill’s approval are concerned over a lack of data and information, and feel the benefits do not outweigh the risks.

My 0.02

I hate taking pills.  I hate feeling ill from taking pills even more.  I especially run from pills that may potentially harm me, or come with ludicrous warning labels and side effects.  Just not worth it.

I’ve always felt that Big Pharma is lookin’ for that Next Big Thing to make a buck.  Many people do not agree that this pill is the “viagra for women” since the chemical and physical reactions of viagra versus Flibanserin are completely different: it does not increase blood flow to a sexual organ; it increases and decreases chemicals within the woman’s brain to alter sexual interest.  “Viagra for women” may be a general misleading and miscategorized statement.

So, if this pill hits the market, I’ll avoid it.  A little prompting by my very patient partner goes a long way in reminding me just how much I’ve missed sex.  Just because I don’t have a sense of initiation any further doesn’t mean I want it any less.  I just…forget…how much I want it.  However, that being said, I know there are a lot of women who may want to pursue this little pill route; and more power to them.

But I am curious and will continue to follow these stories as they break.

What are YOUR thoughts? I’d love to hear them…leave a comment below.

Resources:

AAI Pharma

Flibanserin-HSDD – timeline

Forbes – 6/4/15 article

Google Patents – September 2014 – Method for the Treatment of Premenstrual and other Female Sexual Disorders

Google Patents – June 2014 – Use of Flibanserin for the Treatment of Post Menopausal Sexual Desire Disorders

GTCR – re: Actient Pharmaceuticals

Halozyme

Hyman, Phelps & McNamara, P.C.

International Business Times – 6/8/15 article

MedCity News – 4/4/12 article

National Post – 6/5/15 article

National Women’s Health Network – 6/3/15 press release

Science 2.0 – 6/6/15 article

Sprout Pharmaceuticals – 2013 (Article) – Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder : Results from the Begonia Trial (the 24-week study)

Sprout Pharmaceuticals – 2/11/14 press release

Sprout Pharmaceuticals – 6/5/15 press release

Sprout Pharmaceuticals – executive leadership information

Tech Times – 6/8/15 article

Thomas Reuters – 2014 (Abstract) – Flibanserin for Female Sexual Dysfunction

US News – 6/3/15 article

~ Again, I am a layman.  I do not hold any college degrees, nor mastery of knowledge.  Please take what I say with a grain of salt.  If curious, do your own research 😉 Validate my writings.  Or challenge them.  And ALWAYS feel free to consult with your physician. Always.  Yours ~ Lisa

2 thoughts on “New Pill? Viagra for Women!

  1. I’m the same, I’d avoid a tablet if it said anything about side affects like this one. You’re right, it’s not really a Viagra. A Viagra, gets taken and enjoyed over the next couple of hours. This, taking up to 8 weeks to work, doesn’t sit right in my mind, it like being on a course of treatment, what’s the point in that?
    Personally, I wouldn’t say I don’t have a libido, because I do. I would say though, family life (and life in general) does take away from it, I offend myself thinking about it and weighing it up against my tiredness… The tiredness usually wins! I wouldn’t take tablets every day for 8 weeks just to have more regular sex, I’d rather sit down with my partner an see if there was a way to ignite a spark through trying something new, or just reconnecting… The sex industry is massive and although I know there are women out there who do suffer with a non existent libido, I wonder if those women have tried other means for their lack of sex drive, before headin in the direction of pills that may or may not work.
    A female Viagra would be good, no doubt there is a huge market for it, but it shouldn’t be rushed and it should be exactly that, a female version of what mean have, a sex drive enhancer, not something that may or may not work and/or make you sick… Sorry, long reply lol

    Liked by 1 person

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s