It Takes a Movement: FDA Advisory Panel Recommends Approval of “Little Pink Pill”

Contributed by: Lisa Larkin, MD, FACP, NCMP, IF, Director, UC Health Women’s Center, Associate Professor Obstetrics and Gynecology; Director, Division Midlife Women’s Health and Primary Care

As a practicing women’s sexual health internist, a teacher to medical students and residents, and a current breast cancer patient myself I have a profound dedication to providing women access to treatment options for their health needs.

During my training to become an internist, I had no idea I would specialize in female sexual health. My journey to sexual medicine came about because of my patients – women with unmet sexual health needs, most of them related to a loss of interest in sex. These were women whose relationships both in and out of the bedroom have suffered because a loss of sexual desire for their partner. I became dedicated to these patients, believing they deserve solutions and the right to a treatment option for their sexual dysfunction.

That was 25 years ago. Today, I serve as the Director of the UC Health Women’s Center and the UC Health Menopause and Sexual Health clinic. In my role as a busy clinician, I continue to see patients day after day with the same story and unmet sexual health needs. Twenty-five years later and nothing has changed.  Until recently, the FDA gave us hope. A panel of medical experts voted to recommend approval of flibanserin, or ADDYI, which could become the first and only treatment for hypoactive sexual desire disorder (HSDD).

HSDD is real. It causes distress. There is a clear biologic basis. And we have tools to diagnose it in our office. I do it every single day.

I believe ADDYI should be approved. It should be approved because of the totality of the data – both efficacy and safety. Women who took ADDYI showed significant improvements at every point of measure for the conditions my patients ask me about every day – increase in sexual desire, decrease in distress from the loss of sexual desire and increase in the number of satisfying sexual events.

And what’s more is that the women who experienced positive change agreed with the science. They reported on what improvements were meaningful to them, and the majority said that ADDYI helped to amend the relationships they had been struggling with for years due to HSDD.

Regarding safety, I am passionately outspoken and frequently lecture about the potential dangers of the unregulated, untested and unproven compounded medications and supplements frequently used by my patients. Specific to ADDYI, as a breast cancer patient, I was particularly interested in the breast cancer rodent study data presented at the FDA meeting, and left feeling absolutely unconcerned with the suggestion that risk was increased in animals. ADDYI was studied in more than 11,000 patients. Eight thousand patients took active drug. And there were zero cases of breast cancer.

ADDYI has known potential side effects just like every other medication. No medication is 100% free from risks, but the data shows the potential side effects are largely mild to moderate, and are uncommon. Rare in fact. There are also side effects that are commonly seen with other medications I frequently prescribe – nausea, dizziness and sleepiness. A far cry from the potential side effects associated with FDA approved drugs for male sexual dysfunction, which include penile rupture or even death.

ADDYI will not be appropriate for all women, but for those who it would benefit, the risks are manageable with appropriate risk/benefit discussions – something I do with all my patients. It will be similar to how I talk to women about the risk/benefit of daily aspirin for stroke prevention, hormone therapy for treatment of postmenopausal vasomotor symptoms, Coumadin for Afib, Ditropan for overactive bladder, and even chemotherapy for early stage breast cancer.

Having an FDA approved medication for HSDD is critical for other reasons. It would allow me to accurately and completely discuss risks and benefits with my patients based on solid data. Right now, without any FDA approved options, women suffering with HSDD are using untested, unregulated and unstudied products. Products that are not effective and pose significant consumer safety risks. History was made with the FDA advisory committee’s positive vote, and it is my hope – for my patients, for all patients, for all women – that the FDA’s next step will be to approve the first treatment for HSDD. In my practice, I have been waiting for more than 25 years. Women have been waiting much longer, and it is time we provide them with the options they deserve.

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