Addyi: Still Good the Morning After?

I am dismayed at the FDA’s approval of Addyi (flibanserin) the first drug to treat low sex desire in pre-menopausal women.

To call this new drug the “Pink Viagra” is not medically accurate.

Unlike Viagra, which works by increasing blood flow to a man’s penis, Addyi works on the central nervous system and affects three brain neurotransmitters: increasing dopamine and norepinephrine (both responsible for sexual excitement) while decreasing serotonin (responsible for sexual satiety/inhibition), according to FDA briefing documents.

Addyi is a brain-altering drug, which has potentially serious side effects on women who take birth control, antidepressants, migraine medications or drink alcohol, according to FDA briefing documents.

I am also concerned that Addyi will be used off-label for people who were not tested in the clinical trials, particularly post-menopausal women, due to unknown side effects. This also was a serious consideration for an FDA Advisory Committee panel who met in June 2015 to evaluate the clinical trials for this drug.

So let’s not perpetuate this myth that there is some kind of gender inequality because there are approved drugs that help men with sexual functionality and none for women. Sexual response in a woman cannot be treated in the same way as a man’s which involves the mechanics of erectile dysfunction. Sexual desire in a women is more complex.

To draw a parallel by calling this new drug “Pink Viagra” is just marketing hype, which was part of a targeted and calculated PR campaign, developed by a group called Even the Score.

Why? This was the third time the FDA reviewed Addyi, because the drug failed to meet the FDA’s standard for safety and efficacy twice, in 2010 and 2013, due to side effects.

In June 2010, the Reproductive Health Drugs Advisory Committee met to discuss the New Drug Application (NDA) for flibanserin (Addyi) and felt that “the drug’s impact was ‘not robust enough to justify the risks,’ which include dizziness, nausea and fatigue, particularly with long-term daily use,” according to a report in The New York Times.

The company which initially developed the drug, Boehringer Ingelheim, applied to the FDA for flibanserin (Addyi) as an antidepressant. They hoped it would boost sexual desire in premenopausal women who were distressed by diminished libidos, which affects depression.

But in August, 2010, the FDA didn’t approve it because the drug did not increase women’s libido sufficiently, according to a report in The New York Times. So BI discontinued its development, and sold it to Sprout Pharmaceuticals, Inc.

Early in 2013, Sprout resubmitted the new drug application for flibanserin to the FDA, but in December, the agency rejected it again due to safety concerns, particularly related to driving impairment, as 9.8 percent of women experience somnolence, or sleepiness on the drug, according to Sprout.

When Sprout went back to the FDA in 2014 (the drug’s third review with the agency), the company had a lot at stake: $50 million by private investors, according to Forbes.com.

No wonder Sprout partially financed Even the Score to seed the message of gender bias during the approval process, by hammering on the issue of women’s unmet need for sexual satisfaction.

The campaign seems to have worked. The burden of risk is squarely on patients. And we should be aware of the heavy precautions that the FDA has mandated for use and distribution.

According to the FDA press release, Addyi is being approved with a risk evaluation and mitigation strategy (REMS), because an interaction between Addyi and alcohol increases the risk of severe hypotension (low blood pressure) and syncope (loss of consciousness).

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

The FDA included a black box warning on the prescription label and will require the drug maker to conduct post-marketing studies about Addyi’s interaction with alcohol. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” Dr. Woodcock added.

A sobering message about a drug with a long history of safety issues.

Do women really want to take a pill every day to increase their libido?

Some women may, judging from the passionate testimonials I heard from women and their partners attending the Advisory Committee hearing in June, 2014. According to a study published in the International Journal of Women’s Health in 2010, “female sexual dysfunction (FSD) is a real burden for many women and approximately one in ten women may receive a diagnosis of HSDD.”

But how many women are willing to give up alcohol entirely to take this drug? How many women who have migraines will have to make a choice between the risk associated with taking Addyi and treating the blinding pain of their migraines?

And what about the cost? Sprout told Medical Marketing & Media that the company will likely establish a monthly price that is similar to the monthly cost of other erectile dysfunction treatments, which typically run about $400 without insurance.

In addition, insurance should cover part of the cost when the drug is prescribed for the population and diagnosis on the drug label. But women who take the drug off-label should be careful of medical and financial side effects, because insurance does not typically cover off-label use.

Sources:

FDA Briefing Document. FDA. Retrieved August 24, 2015.
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM449088.pdf

June 4, 2015: Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement. FDA. Retrieved August 24, 2015.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm446094.htm

Drug for Sexual Desire Disorder Opposed by Panel. The New York Times. Retrieved August 24, 2015.
http://www.nytimes.com/2010/06/19/business/19sexpill.html?_r=0

Following regulatory feedback Boehringer Ingelheim decides to discontinue flibanserin development. Boehringer Ingelheim. Retrieved August 24, 2015.
http://us.boehringeringelheim.com/news_events/press_releases/press_release_archive/2010/october_8_2010.html

More Complicated Than 'Pink Viagra': What You Should Know About Flibanserin (Addyi). Forbes. Retrieved August 24, 2015.
http://www.forbes.com/sites/davidkroll/2015/06/04/more-complicated-than-pink-viagra-what-you-should-know-about-flibanserin-addyi

FDA Approves Female Libido Pill, but Includes Safety Warnings. Newsworks. Retrieved August 24, 2015.
http://www.newsworks.org/index.php/health-science/item/85366-fda-approves-female-libido-pill-but-includes-safety-warnings

FDA Approves First Treatment For Sexual Desire Disorder. FDA. Retrieved August 24, 2015.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm458734.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Sexual problems and distress in United States women: prevalence and correlates. Pubmed. http://www.ncbi.nlm.nih.gov/pubmed/18978095

Reviewed August 25, 2015
by Michele Blacksberg RN
Edited by Jody Smith

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Tags:

• Hypoactive Sexual Desire Disorder (HSDD)
• Sexual Health