FDA trial requirements and endpoints

This week on unPaused, Dr. Mary Claire Haver sits down with Cindy Eckert, founder and CEO of Sprout Pharmaceuticals and creator of Addyi, the first FDA approved treatment for low libido in women. Cindy is a pharmaceutical entrepreneur who began her career at Merck before founding her first company in 2007, focusing on undermarketed FDA approved products. After successfully building and selling a male sexual health company, she became the only woman running a sexual health company and witnessed firsthand the stark contrast between how medicine treats male versus female sexual dysfunction. Her journey to bring Addyi to market became a cultural battle about whether women's sexual desire matters, leading to two FDA rejections, public hearings, and ultimately a historic approval in 2015 after a six year fight.

In this conversation, Dr. Haver and Cindy explore how Addyi works differently from Viagra, targeting brain chemistry and desire rather than blood flow and arousal. Cindy explains that Addyi is a mood drug originally developed for depression that showed an unexpected effect on female libido during clinical trials. The medication works on neurotransmitters in the brain, building over approximately eight weeks to restore spontaneous thoughts, fantasies, and desire in women with hypoactive sexual desire disorder or HSDD. She walks through the massive clinical trial requirements, including 13,000 patients compared to Viagra's 4,000, and the three things they had to prove with statistical significance versus placebo: increased interest in sex, more satisfying sexual experiences, and decreased distress from the condition.

ADDYI, flibanserin, is for women <65 with low sexual desire disorder who have not had problems with low sexual desire in the past, and who have low sexual desire that is troubling to them no matter the type of sexual activity, situation, or sexual partner. The low sexual desire is not due to a medical or mental health problem, problems in the relationship or medicine or other drug use. ADDYI is not for men or to enhance sexual performance.

Your risk of severe low blood pressure and fainting is increased if you drink 1-2 standard alcoholic drinks close in time to your ADDYI dose. Wait at least 2 hours after one to two drinks before taking ADDYI at bedtime and skip your dose if you drink three or more drinks that evening. If you take certain prescription, OTC or herbal medications, or have liver problems, the risk of low blood pressure and fainting increases and you should not take ADDYI.   Do not take if you are allergic to any of ADDYI’s ingredients. Sometimes serious sleepiness can occur. Common side effects include dizziness, nausea, tiredness, difficulty falling asleep or staying asleep and dry mouth. See PI and Boxed Warning at addyi.com/pi
Guest links:

• Cindy Eckert 

• Cindy Eckert (Instagram)

Recommended Books:

• “Mars and Venus in the Bedroom: A Guide to Lasting Romance and Passion,” by John Gray

Articles:

• Women with hypoactive sexual desire disorder compared to normal females: a functional magnetic resonance imaging study (Neuroscience)

• Sexual Dysfunction Induced by Antidepressants—A Pharmacovigilance Study Using Data from VigiBaseTM (Pharmaceuticals)

• Enhancing Sexual Health for Cancer Survivors (Symptom Science And Palliative Care)

• Flibanserin Approval: Facts or Feelings? (Sexual Medicine)

• Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012 (JAMA)

Other Resources:

• Addyi

• What is Patient-Focused Drug Development?

• International Society for the Study of Women's Sexual Health (ISSWSH)

• FDA Expands Approval of Flibanserin for Postmenopausal Women’s Sexual Health (Drug Topics)

• A Pill for Sexual Desire Reaches a New Group of Women (TIME Magazine)
  Drug Trials Snapshots Summary Report 2024 (FDA)

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