Flibanserin May Finally Be Approved for Help With Libido!

By on July 1st, 2015 Categories: Sex Matters

As you know, at the time of last month’s blog publication, I was in Washington D.C. attending the Food and Drug Administration (FDA) Advisory Committee on the drug flibanserin. Studies have demonstrated that flibanserin can increase sexually satisfying events and decrease the distress associated with low desire.

The world was watching as hundreds of sexual medicine experts descended on Washington to witness history. Would the committee vote for approval or send drug development for women’s sexual health concerns back to the Stone Age? I was one of 30 experts chosen to speak at the open forum. I had the opportunity to show a video from the Women’s Initiative in Sexual Health (WISH) featuring the diverse group of men, women, therapists, and the variety of healthcare professionals who are dedicated to equal drug development and approval for sexual health issues.

I was able to catch up with a longtime friend and colleague, Lisa Larkin, M.D., F.A.C.P., N.C.M.P., who specializes in internal medicine, women’s health, sexual medicine, and menopause. She is director of the Division of Midlife Women’s Health and Primary Care in the department of obstetrics and gynecology at the University of Cincinnati. Dr. Larkin is also a breast cancer survivor.

Dr. Larkin is a passionate advocate for women and their unmet health needs, particularly in the areas of sexual health, menopause, and survivorship.  She also attended the FDA Advisory Committee as a supporter of women and their unmet sexual health needs to raise awareness of lowered libido. I share with you our interview!

MK: What have studies shown about how well flibanserin works to enhance or improve libido? Can you share the data in simple terms?

LL: Flibanserin has been studied in over 11,000 women, making it one of the most studied women’s health medications. In three trials, women with lowered libido taking flibanserin, a tablet taken at night, had a 53% increase in sexual desire, a 29% decrease in distress related to a loss of desire, and a doubling in the number of sexually satisfying events.

MK: Why did the FDA vote down the approval of this drug two times previously?

LL: The FDA did not vote “down” the approval of flibanserin in 2010 and 2013, but they felt there was a need for more data to show that the drug is effective, and they had concerns about safety and some drug interactions. The endpoints (the main result measured at the end of a study) were changed to be more meaningful for women in over 10 new studies, which demonstrated good effectiveness in increasing desire and decreasing distress. Safety issues were also reexamined.

The FDA requested some additional studies. The additional studies demonstrated that the drug was effective. The studies also clarified drug interaction concerns and re-examined the safety of the drug.

MK: For breast cancer patients, here is a hypothetical case I see all the time in clinical practice: “I’m 35. I was diagnosed with estrogen-receptor-positive breast cancer and had my ovaries removed as part of my treatment. Am I a candidate for flibanserin if it is approved?”

LL: Flibanserin is a non-hormonal medication that is completely unrelated to testosterone or estrogen. Flibanserin works centrally in the brain to adjust a variety of neurotransmitters (chemicals that transmit signals in between the nerve cells of the brain) that are believed to regulate sexual desire. Specifically, Flibanserin increases the neurotransmitters dopamine and norepinephrine and decreases serotonin, which results in an increase in sexual interest.

Flibanserin is similar to antidepressant medications, which are safe for most women with a history of breast cancer. Additionally, flibanserin was studied in 11,000 women, but not specifically studied in a breast cancer population. You should always consult your healthcare provider before taking any medications and ensure that the medication is right for your individual situation and diagnosis.

MK: How is flibanserin taken? Are there side effects I need to know about?

LL: Flibanserin is a tablet that is taken orally each day at bedtime. In most women it is very well tolerated. The most common side effects seen are sleepiness, dizziness, and nausea, which are minimized when taken at bedtime. The media has mentioned issues related to lowered blood pressure and fainting; however, the incidences were extremely low. For some perspective on this, in the antidepressant Wellbutrin (chemical name: bupropion), the incidence rate of low blood pressure is 2.5%, or 12 times the flibanserin rate. In addition, Wellbutrin has a fainting incidence rate of 1.2%, or 4 times the flibanserin rate.

In the studies, 9.6% of women stopped the medication due to side effects compared to 3.7 % of women in the placebo group. The side effects may increase when combined with alcohol, so alcohol should be avoided. Side effects can also increase if taken with antifungal medication, so it’s important to talk to your doctor if you’re taking an antifungal. Most side effects resolved within a few weeks of taking the medication.

***

Flibanserin, if approved in August 2015, would be the first and only medication that would be available for hypoactive sexual desire disorder (HSDD). It’s a nonhormonal medication and although not specifically indicated for or studied in breast cancer patients, it may hold promise for many women who are suffering and have no current solution.

Michael L. Krychman, M.D.C.M., is the executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California. He is the former co-director of the Sexual Medicine and Rehabilitation Program at Memorial Sloan-Kettering Cancer. Dr. Krychman is also an American Association of Sexuality Educators, Counselors and Therapists (AASECT) certified sexual counselor. He is an associate clinical professor at the University of California, Irvine, Division of Gynecological Oncology, and the medical director of Ann’s Clinic, a high-risk program for breast and ovarian cancer survivors. His special interests include menopausal health, hormone therapy, sexual pain disorders, loss of libido, and chronic medical illness and its impact on female sexual function as well as breast cancer sexuality. Dr. Krychman is also a member of the Breastcancer.org Professional Advisory Board.

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