(This post was originally published on June 8, 2015.  As of April 19, 2018, it was updated to include new information)

In 2015, the FDA advisory committee was pushing for the approval of a new drug, Addyi (aka flibanserin), which is being hailed as “viagra for women.”  The drug was approved on August 18, 2015. Many women suffer from a low sex drive for many different reasons.  I myself had suffered with it since my Lupron Depot injections, which were immediately followed by a continuous birth control.  My libido was nearly non-existent for almost two years.  Since I stopped taking birth control pills, however, it returned full-force!

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 effects 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 its 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 is 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 was 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.

Two days after Addyi was approved by the FDA, the owner of Sprouts Pharmaceuticals sold the company and product to Valeant Pharmaceuticals.  However, due to investor complaints of low sales and poor marketing, Valeant sold the company back to Sprouts’ original owners.  The questoin was raised: were sales poor because of bad marketing…or because of risky 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 had tried twice since 2013 to have the FDA approve the drug, and failed, before their 2015 approval.

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 felt 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.

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…

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.

Addyi (Flibanserin) is now available by prescription.  I, however, will avoid it.  A little prompting by my very patient partner went a long way in reminding me just how much I missed sex.  And I’m grateful to have my libido back in full-swing.  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.

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

**Updated April 19, 2018**

Resources:

AAI Pharma

Flibanserin-HSDD – timeline

Forbes – 6/4/15 article

Fortune – 11/7/17 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 Food & Drug Administration – Addyi information

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