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Addyi Explained: Medical Breakthrough or Marketing Marvel?

Medically reviewed on Aug 28, 2017 by L. Anderson, PharmD

Is Addyi Just a Pink Viagra?

Some drugs always make the headlines, so you've probably heard about Addyi by now. It's also known as flibanserin and was approved by the FDA in August, 2015 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. That's just another of way saying it boosts sex drive (libido) in certain women.

It is not a "female Viagra" or a "pink Viagra". In fact, it works very differently from the erectile dysfunction class of drugs used in men. Addyi works to balance brain chemicals (neurotransmitters) that may be responsible for the lowered sex drive in some women. It is the first such drug approved for this use.

How Does Addyi Work?

Drugs always seem to be in complicated drug classes, and Addyi is, too. Addyi is a non-hormonal, multifunctional serotonin agonist antagonist (MSAA). Addyi corrects an imbalance of the neurotransmitters (brain chemicals) dopamine and norepinephrine (both responsible for sexual excitement), while decreasing levels of serotonin (responsible for sexual satiety/inhibition), although the exact mechanism is not known, according to FDA.

Don't get caught up in all the specifics, however. The takeaway from all of this? Addyi works in the brain and many of it's side effects, like dizziness and drowsiness, are due to it's central nervous system action, too.

Is Addyi Effective?

The answer to this question may depend upon who you ask.

The effectiveness of Addyi was evaluated in three 24-week clinical trials in 2,400 premenopausal women with HSDD. On average, taking Addyi increased the number of satisfying sexual events by 0.5 to 1 additional event per month over placebo. Roughly 10% more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress.

But a more recent 2016 study in JAMA Internal Medicine found that effectiveness was even lower: treatment with Addyi, on average, resulted in only one-half additional satisfying sexual event per month while significantly increasing the risk of some troublesome side effects, like dizziness, somnolence, nausea, and fatigue.

However, there may be a certain subset of women who have significant success with Addyi to boost libido. Discuss with your doctor if a trial of Addyi is a wise option for you.

Am I A Candidate For Addyi?

Addyi has been given the green light by FDA (with restrictions) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

HSDD is acquired if you previously had normal sexual desires, and it's generalized when your low libido occurs no matter the sexual activity or partner. There are other prerequisites to be a candidate for Addyi, too: your low libido must also cause marked distress or an interpersonal difficulty. If the low sex drive is due to a co-existing medical or psychiatric condition (for example, depression), problems with a significant other (husband, partner), or due to side effects of a drug, then Addyi is not for you.

What's the History Behind Addyi?

Originally, flibanserin was under research as a depression treatment. When FDA rejected the drug for libido in 2010, Boehringer Ingelheim unloaded the drug to Sprout Pharmaceuticals. Under Sprout's development, flibanserin as a treatment for low libido in women was rejected two more times by the FDA. Advisory members stated lack of effectiveness and risky side effects.

However, Sprout forged ahead, rounding out studies, creating "disease awareness", and continuing to work with FDA to gain Addyi approval to much controversy. On August 20, 2015 Valeant Pharmaceuticals acquired Sprout and Addyi for a cool $1 billion in cash.

Why So Much Buzz With Addyi?

Women's groups heralded the approval of Addyi as finally meeting a significant unmet need. Based on studies, there may be a small group of women for which this drug is effective. However, if no results are seen after 8 weeks, the drug should be stopped, according to package labeling.

Common side effects include dizziness, nausea and sleepiness. The risk of fainting, particularly when combined with alcohol, is also a major concern. Addyi is taken each night, and patients must fully abstain from alcohol use while using the drug.

Some physicians question the real-world possibility of separating sex from alcohol use on a full time basis. Doctors are tasked with assessing this risk in their patients.

Even The Score: Disease Awareness Fast-Tracked

After the second rejection of flibanserin, women's healthcare groups formed "Even the Score", an ad campaign at least partly funded by Addyi's manufacturer. It's goal: to bring awareness of women's low libido to the forefront, as well as remind the public, and FDA, that men currently had over 26 treatments for sexual dysfunction, while women had none.

Proponents complained of "gender bias" against women. Drug promotion prior to approval is prohibited, so opponents were outraged that such a "disease awareness" campaign might influence FDA advisory committees.

Pick Your Role: Doctor, Pharmacist or Patient

Because of the risk of low blood pressure and fainting when Addyi is combined with alcohol, doctors and pharmacies must complete REMS online education to become certified.

In addition, providers must "assess the likelihood of the patient abstaining from alcohol" based on past history. Pharmacists need to counsel the patient to avoid alcohol when the prescription is dispensed. Addyi should not be prescribed to patients with liver disease or at risk of certain drug interactions. Patients should always have an Addyi drug interaction screen done by their pharmacist with new prescription drugs, OTCs or herbal products.

How Do Women Take Addyi?

Addyi is taken as an oral 100 mg dose at bedtime, each night; and yes, it's pink.

It's important to follow directions< and take the dose just before bed to decrease the risk of injury due to low blood pressure, fainting, and sleepiness. These effects can occur even if Addyi is NOT combined with alcohol. Be aware that when it's combined with other drugs that also cause drowsiness - like some antihistamines, pain pills, anxiety drugs or sedatives - your sleepiness will be enhanced. Don't take Addyi during waking hours. Driving or other hazardous activities should be avoided for at least 6 hours after a dose.

Nausea, insomnia, and dry mouth are other possible side effects with Addyi.

Questions: Addyi Use

Addyi is only approved for use in premenopausal women, but does it work in post-menopausal women?

Will it work in men to boost sexual desire? Since it affects brain neurotransmitters, which we all have, there is a possibility it might produce a result, although clinical trials would be needed.

And what about the biggest question of all: cost? The cost of Addyi is very expensive; over $800 per month if you're paying cash. That's a lot of money to dole out if your insurance won't pay for it.

In fact, sales have been scant and blockbuster status elusive: as reported in Forbes roughly 250 prescriptions were being written per week in 2016 with revenue of about $11 million per year.

Addyi: The Bottom Line

Still thinking about trying Addyi? It's important to understand this drug before you start taking it.

Fully read the FDA-approved Medication Guide and ask your doctor or pharmacist any questions you have. There are many restrictions with this drug, so be sure you follow them.

Also, be sure you are an appropriate candidate for Addyi, and understand that it's not effective in all women. If you have marital or relationship problems, mental health issues, or lack of sex drive due to a medication, Addyi is not for you; other medical options or counseling may be the better answer.

However, for women that are candidates for Addyi and that have success with the drug, it might be the answer they are seeking.

Finished: Addyi Explained: Medical Breakthrough or Marketing Marvel?

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Sources

  • Jaspers L, Feys F, Bramer WM, et al. Efficacy and Safety of Flibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Women: A Systematic Review and Meta-analysis. JAMA Intern Med. 2016;176(4):453–462. doi:10.1001/jamainternmed.2015.8565 Accessed August 28, 2017 at http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2497781
  • U.S. Food and Drug Administration (FDA). Drugs@FDA Addyi. Accessed August 28, 2017 at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails.
  • Addyi Prescribing Information. Valeant Pharmaceuticals. Revised 08/2015. Accessed June 21, 2016 at https://www.drugs.com/pro/addyi.html
  • Pollack A. FDA Approves Addyi, a Libido Pill for Women. The New York Times. Accessed August 28, 2017 at http://www.nytimes.com/2015/08/19/business/fda-approval-addyi-female-viagra.html
  • FDA Briefing Documents. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee. Flibanserin. June 4, 2015. Accessed August 28, 2017 at http://ow.ly/RybWO
  • LaMattina J. Why Is No One Buying 'Pink Viagra'?Forbes. March 19, 2016. Accessed August 28, 2017 at https://www.forbes.com/sites/johnlamattina/2016/03/09/where-are-all-the-women-with-arousal-disorder/#5f6334e334b9
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