11:24am Friday 24 November 2017

Is Viagra for women on horizon?

Saketh Guntupalli, MD, assistant professor of Obstetrics and Gynecology in the CU School of Medicine, talks during an Aspen Ideas Festival session about a potential new drug to boost women’s libido. Photos by Matt Kaskavitch, University Communications.

By Chris Casey | University Communications

ASPEN, Colo. — The promise of improved sexual function, set in motion 17 years ago with the Food and Drug Administration’s approval of the male erectile dysfunction drug Viagra, is behind the push for a new drug that could boost women’s libido.

But questions about the safety and efficacy of the drug, Filbanserin, which has been in development for decades and has gone before the FDA three times, loom as it nears final approval.

A panel featuring CU School of Medicine Assistant Professor of Obstetrics and Gynecology Saketh Guntupalli, MD, discussed the topic, “Does Women’s Viagra Turn You On” as part of the Aspen Ideas Festival’s Spotlight Health series on June 26. The CU Anschutz Medical Campus and its partners — the CU School of Medicine, University of Colorado Hospital and Children’s Hospital Colorado — were presenting underwriters of this year’s series.

Johnson, Guntupalli and Katz
The panel discussion featured, from left, Paula Johnson, MD, professor of medicince at Harvard Medical School and executive director of the Connors Center for Women’s Health and Gender Biology; Saketh Guntupalli, MD, assistant professor of Obstetrics and Gynecology in the CU School of Medicine; and Ruth Katz, executive director of the Health Medicine and Society program at The Aspen Institute.

The discussion also featured panelist Paula Johnson, MD, professor of medicine at Harvard Medical School and executive director of the Connors Center for Women’s Health and Gender Biology, and moderator Ruth Katz, executive director of the Health Medicine and Society program at The Aspen Institute.

As one might expect on such a subject, the discussion was lively, informative and at times entertaining. It also touched on the wider issue of inequities in research on women’s health issues.

Very different than Viagra

Guntupalli stressed that the drug Filbanserin works in very different ways than Viagra. Viagra keys on the physiological problem of achieving an erection rather than psychological issues, because with men, sexual desire generally isn’t the problem.

Filbanserin, conversely, works on the brain through serotonin receptor pathways. “It helps women overcome hypoactive sexual disorder, or the inability to have desire,” Guntupalli said.

He noted that side effects suffered by some participants in the clinical trials included dizziness, nausea and fainting. Overall, the trials showed that women experienced increased libido as well as “satisfying sexual events,” which in women tend to be subjective.

Guntupalli said he recently contacted Sprout Pharmaceuticals, the maker of Filbanserin, about the possibility of conducting a clinical trial with some of his patients. Guntupalli specializes in care of women with gynecologic pre-cancer and cancers — the latter group being especially vulnerable, because of cancer treatments, to problems with libido.

In general, he said, 40 percent of women suffer from some form of sexual dysfunction, which can adversely affect their relationships. “We do have to address it, but I think we need to address it in a responsible way.”

Johnson said that although more data has been collected through Filbanserin trials, some concerns persist. “One, what does one additional ‘sexually satisfying experience’ per month mean vs. a placebo, and two, the side effects are still pretty significant.” She said those women feeling fatigue and depression as a side effect of the drug was near 20 percent, and that the interaction between the drug and alcohol remains an under-studied area. One alcohol study done by the drug manufacturer had 25 subjects, but 23 of them were men. When asked about this, Johnson said, the company said it wasn’t successful in recruiting women to participate in the trial.

“If you think about it, we’re going to be marketing this drug to young, pre-menopausal women, but there has been very little study of the intersection between pre-menopausal women, hormonal contraception and the use of alcohol (with the drug),” Johnson said.

Audience member at the Aspen Ideas FestivalAn audience member asks the panel a question during the Q&A session.

‘All about choice’

Guntupalli said he always asks his patients the question: “Does this (problem with sexual function) bother you in your life?” If not, then the discussion about a sexual-function drug is moot.

“There is kind of this dichotomy within this movement that we have to push this drug, we have to address this,” Guntupalli said. “But it’s all about choice. … We should not be pushing this drug on women who don’t want to engage in sexual activity just because as a society we’ve decided that this is such a huge problem.

“For women where (sexual dysfunction) is an issue,” he said, “It’s something that needs attention and it needs to be addressed – safely.”

Guntupalli said data from the NIH and shows that women tend to be underrepresented in disease studies in general, and that needs to change.

Guntupalli and Johnson both said that multifaceted, individualized approaches to care are necessary rather than simple prescriptions for a pill. More concerted work on women’s health issues is needed in general, Johnson said.

“Whether it be the issues of trials, whether it be what the FDA requires to approve a drug … there are so many issues that get sidelined because they don’t fit in a disease category,” she said. “I think this is a major life issue. If we had more of a generalized movement – that included both women and men – we would be in a different place. And we are desperately missing that today.”

Aspen Ideas Festival

The University of Colorado Anschutz Medical Campus was a presenting underwriter of the 2015 Aspen Ideas Festival’s three-day Spotlight Health series. Leading physicians and scholars from the CU Anschutz Medical Campus shared their insights and research with 1,000-plus attendees from June 25-28.

The high-profile Spotlight Health forum is an ideal platform on which to raise the profile of the CU Anschutz Medical Campus.

“The festival takes place in Aspen, our own backyard, and attracts attendees from around the country and the world,” said Leanna Clark, vice chancellor of University Communications. “The Spotlight Health focus ensures that we are getting the Anschutz Medical Campus brand in front of the foremost academics, policy makers, practitioners, industry executives, philanthropists and concerned citizens, and engaging them in the conversation to transform health and health care.”

The Aspen Institute invited a group of “Spotlight Scholars” to attend the conference in recognition of their academic accomplishments and ability to translate ideas into action. Four scholars represented the CU Anschutz Medical Campus: Brandi Freeman, MD, assistant professor, Pediatrics-General Pediatrics; Jason Stoneback, MD, Department of Orthopedics; Roberta Capp, assistant professor, Emergency Medicine; and Christopher Porter, MD, assistant professor, Pediatrics-Hematology/Oncology.

Contact: Christopher.casey@ucdenver.edu


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