Assoc. for Women in Science

Winter 2015

AWIS Magazine covers topics important to women in science, technology, engineering, mathematics, and medicine fields. Topics include career advancement, work-life balance, the state of science and technology, women’s wellness, and AWIS’ political and

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36 association for women in science | winter 2015 wellness a cure for HSDD A new little pink pill called Addyi from Sprout Pharma- ceuticals has finally hit the market. The drug behind it, flibanserin, is being touted as a being the "female Viagra" and is a long-awaited treatment for women suffering from hypoactive sexual desire disorder (HSDD). For more than a decade scientists, physicians and pharma- ceutical companies have been trying to find a cure for HSDD while naysayers saying the condition is all in a women's head. And some critics are pointing out that it can sometimes be only moderately effective, can't be taken with alcohol and has potential side-effects. AWIS decided to go to the source. Dr. Kingsberg is a clinical psychologist, and is a chief of behavioral medicine at MacDonald Women's Hospital and is a reproductive biology professor at the Case Western Reserve University School of Medicine. She is also oversaw local enrollment of clinical trials for flibanserin. AWIS: How did you get involved in becoming a clinical investigator in the flibanserin trials? What prompted you to do so? Dr. Kingsberg: I have been involved in clinical research on treatments for female sexual disorders for 15 years. Our clinical trials unit here at MacDonald Women's Hospital has been a leading site for clinical trials in female sexual health and most sponsors of these trials know me and know our clinical trials unit, thus we are recruited to be a site for trials in female sexual health. We were a site for the flibanserin Phase III trials in both pre and postmenopausal women. AWIS: Why do you think it took over six years for the drug to get approved? Dr. Kingsberg: Boehringer-Ingelheim (BI) developed its Phase III pivotal trials protocol with input from the FDA. This was several years ago and sponsors' and the Food and Drug Administration's (FDA) understanding of desire and how best to measure desire was evolving. The FDA has only recently (thanks to the day two expert panel they convened for their two-day female sexual dysfunction workshop in October 2014) came to understand that short recall for desire is not more accurate. They have felt that daily measurement would decrease recall error but in fact, it is more of a distortion. Desire is best understood as a state and not best recalled with such a narrow range, e.g. 24 hours. So, the FDA had wanted a primary endpoint for the Phase III trials to be a daily diary of desire. This was a flawed endpoint because asking women, particularly women with low desire, to "rate your desire today" is hard for women to distinguish on a daily basis and caused diary fatigue (and non-compliance). Despite this, the endpoint was close to significance for the flibanserin subjects vs. placebo, but did not reach significance. Because this was a primary endpoint, an advisory committee voted no to approval based on BI's request to change the end- point (moving the female sexual function index-desire domain score to primary and the diary to secondary). Obviously you cannot change endpoints in the middle of a trial. Thus, a third pivotal trial in premenopausal women and another pivotal trial in postmenopausal women was conducted but this time using (with the FDA's agreement) the FSFI-desire subscale and satis- fying sexual events (SSE) that are reported within 24 hour, were the primary endpoint and distress (as measured by the female sexual distress scale-revised) was a key secondary endpoint. In these Phase III trials, the treatment group showed statistical im- provement in all three endpoints compared to placebo. BI also decided to walk away from further development of flibanserin and sold the rights to Sprout. However, when Sprout submitted its new drug application (NDA) with its meeting of all the endpoints, the FDA did not approve it due to its perception that the benefit was only "modest" and therefore not effective enough compared to Female Sexual Dysfunction Cure in a Little Pink Pill? A conversation with Dr. Sheryl Kingsberg, a consultant on the flibanserin trials

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