Search For a Provider Facebook Twitter Instagram YouTube ES Contact Us

News

Flibanserin

May 23, 2014

FlibanserinWednesday night, ABC’s “Nightline” program featured the “little pink pill” – a drug called flibanserin – designed to treat hypoactive sexual desire disorder (HSDD) in women.

Thought to affect about one in ten women, HSDD is characterized by low libido that causes distress. Women with HSDD have no interest in or desire for sex and don’t fantasize about it. In addition to a woman’s own frustration, HSDD can lead to conflicts in relationships, too.

Currently, there is no medical treatment for HSDD. Despite encouraging results in clinical trials, flibanserin has not been approved by the U.S. Food and Drug Administration (FDA).

According to ABC, Sprout Pharmaceuticals, the manufacturer of flibanserin, has appealed the FDA’s decision and will conduct two more trials before the agency’s next review.

Cindy Whitehead, COO of Sprout Pharmaceuticals told Nightline, “[The FDA] felt that Flibanserin’s effect was only modest, and, therefore, they didn’t give us an approval.”

The FDA’s decision has sparked a debate over sexism, as there are many drugs available to treat men’s sexual dysfunction but none for women.

“There are 25 drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction]” Whitehead said in the Nightline segment.

In January, the International Society for the Study of Women’s Sexual Health (ISSWSH) commissioned a survey of over 500 American women on the subject. Almost 60% said they thought society emphasizes men’s sexual satisfaction over that of women.

The FDA declined Nightline’s request for an interview and did not comment on flibanserin. In a statement to Nightline, the agency said:

The FDA is committed to supporting the development of therapies for medical conditions related to female sexual dysfunction. The agency has approved treatments for pain during sexual intercourse and vaginal dryness associated with menopause. Additionally, the FDA has also identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention. The agency will be actively soliciting patients’ perspectives on their condition and its impact on daily life.

The FDA cannot discuss any drug that is still under regulatory consideration. The agency evaluates drugs based on science and strongly rejects claims of gender bias. Currently, the FDA continues to work with the company to determine whether the drug’s benefits could outweigh its risks. The FDA strives to protect and advance all important areas of women’s health, and the agency is committed to working with companies to develop safe and effective treatments for female sexual dysfunction.

Learn More

To learn more about HSDD, please click here to see an infographic prepared by Sprout Pharmaceuticals.

These links can also help women and their partners better understand HSDD:

HSDD – The Basics

Overview - HSDD. It’s normal for women to lose interest in sex from time to time. What makes HSDD different is the distress it can cause.

Conditions - HSDD. Physical, psychological, and emotional conditions can all lead to HSDD. This post explains these links.

Diagnosing HSDD. How do doctors know when a woman has HSDD? Distress is a key concept, but it can be different for every woman.

Treating HSDD. HSDD treatment often involves dealing with causes. For example, a woman with diabetes may need to get her blood sugar under control. If a woman’s low desire stems from problems with her partner, couples counseling may be suggested.

Understanding HSDD. Targeted to healthcare providers, this article explains HSDD and offers guidance for clinicians who may not be well-versed in sexual medicine.

Do I Have HSDD?

Looking at HSDD. This blog post is for women with low sexual desire and explains why seeing a doctor can help.

Decreased Sexual Desire Screener. This questionnaire helps women assess their symptoms.

HSDD and the Brain

Female Sexual Health. What is the most important sex organ in a woman’s body? The vagina? The clitoris? How about the brain?

Brain Activation Patterns in Women with HSDD. Scientists discovered that when shown sexually explicit images, the brains of women with HSDD react differently than those without HSDD.

HSDD and Brain Anatomy. Researchers have also found that women with HSDD have structural differences in the brain when compared to women without the condition.

HSDD and Partners

Talking About HSDD. HSDD can be difficult for partners to cope with and talk about. Many fear that they are no longer attractive to their female partner. This blog post helps partners better understand HSDD and provides tips for talking about it.

HSDD Treatment

Latest News on Lybrido/Lybridos. Clinical trials on two drugs designed to treat HSDD are underway. If the trials are successful, medication could be available by 2016.

 

Resources

ABC News/Nightline

Schiavocampo, Mara, Jackie Jesko, and Lauren Effron

“Fight Over 'Little Pink Pill' Raises Sexism Questions”

(Article and video segment. May 21, 2014)

http://abcnews.go.com/Health/fight-pink-pill-boosting-womens-sex-drive-raises/story?id=23813586

Sexual Medicine Society of North America

“American Women’s Views on Sexual Health Treatment Options”

(March 12, 2014)

http://www.sexhealthmatters.org/news/american-womens-views-on-sexual-health-treatment-options