Is Addyi just a pink Viagra?

Official answer

by Drugs.com

No, Addyi is not a "female Viagra" or a "pink Viagra", as you may have heard. Addyi works differently by balancing brain chemical messengers that may be responsible for the lowered sex drive in some women. It is not used to enhance sexual performance.

Erectile dysfunction drugs like Viagra or Cialis increase smooth muscle relaxation and the inflow of blood to the spongy tissue in the penis to cause an erection.

Addyi is also known generically as flibanserin and was approved by the FDA in 2015 to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. That's just another of way saying it boosts sex drive (also called libido) in women who have not reached menopause. It was the first such drug approved for this use.

HSDD is the most common type of female sexual dysfunction, affecting roughly 6 million premenopausal women in the U.S.

Addyi was approved by the FDA for a very specific use for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

How does Addyi work in HSDD?

Addyi is classified a non-hormonal, multifunctional serotonin agonist antagonist (MSAA).

Addyi is not approved for use for the treatment of HSDD in women who have gone through menopause or in men or children. It is used to enhance sexual performance.

Is Addyi Effective?

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 (10 out of every 100) Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress.

But a 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:

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

Am I a Candidate for Addyi?

Addyi is approved by the FDA (with limitations) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. It's not used to boost sex drive in postmenopausal women or in men.

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. In addition, your low libido must also cause marked distress or an interpersonal difficulty.

If your low sex drive is due to:

then Addyi is not for you.

What's the History Behind Addyi?

Originally, flibanserin was under research as a depression treatment. When FDA rejected approval of the drug for libido in 2010, Boehringer Ingelheim sold 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" in the general public and with healthcare providers, and continuing to work with FDA to gain Addyi approval.

On August 20, 2015 Valeant Pharmaceuticals acquired Sprout Pharmaceuticals and Addyi for a massive $1 billion in cash, two days after Addyi approval.

Why Was There So Much Buzz With Addyi?

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

Addyi has some side effects that are worth knowing about, too, including an interaction with alcohol. Common side effects with Addyi include:

A New Boxed Warning in labeling from the FDA regarding alcohol and Addyi use were published in April 2019.

If you skip a dose of Addyi, take your next dose at bedtime the next day.

Combining Addyi with alcohol may also increase the risk of low blood pressure and fainting, which is problematic especially if you are driving, doing hazardous activities, or need clear thinking or reaction times.

This is not all the information you need to know about Addyi for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.