Addyi, the new pink pill for women’s libido, has caused quite a stir. Not only was Sprout Pharmaceuticals, the drug company that developed it, sold to Valeant Pharmaceuticals International for about $1 billion within 48 hours of the pill winning FDA approval, it was recently reported that the drug, which was twice rejected by the FDA, caused considerable dissent within the agency on its way to being approved in August. Cindy Whitehead, the CEO of Sprout Pharmaceuticals, sees the outcome of what amounted to years of work as a dream come true. After listening to stories of women with Hypoactive Sexual Desire Disorder, she said it’s her greatest privilege to finally offer them hope.
Whitehead managed to champion Addyi, which is expected to be available next month, on its way to approval with a small team of 25, and she characterizes the significant feat like this: “Every member of Sprout shared a single purpose — to see this through for women. We believed that science would ultimately win the day and when it did so, too, would the women who were dealing with the very real impact of this medical condition. The choice should be theirs to make — not anyone else’s to judge.” Whitehead chatted with Women In The World over email about what the deal means to her and to the future of all women.
Women In The World: Addyi has been given the nickname “the female Viagra,” which you’re not a fan of, but how does it compare to Viagra?
Cindy Whitehead: Addyi has the potential to be the same kind of game changer for women’s sexual health as Viagra was for men’s — but the comparisons stop there. It should come as no surprise to any of us that desire in women is not a blood flow issue! Nor are women on-demand creatures when it comes to sex. Addyi works on key chemicals in the brain that are known to be involved in sexual excitement or inhibition — you take it daily at bedtime. Viagra works on increasing blood flow as needed.
WITW: How did this drug come to fruition?
CW: Like many drug discoveries, Addyi was discovered “by accident” while being studied for something else. Researchers uncovered Addyi’s unique effect on sexual desire and changed the course of study to look at whether or not it could treat Hypoactive Sexual Desire Disorder (HSDD). Interestingly, Viagra was also discovered by accident. It was being studied for blood pressure when it’s effect on erectile dysfunction was discovered.
WITW: What is the efficacy like?
CW: The way in which Addyi works is similar to other medications that effect brain chemicals, like antidepressants, not medications that are quick fixes. The effects seen with these types of drugs are usually those subtle shifts back toward restoring a person’s individual normal they once knew but had lost. With this type of mechanism, a woman who doesn’t have the dysfunction isn’t going to see effect –- just like a patient who isn’t depressed wouldn’t take a medication and become euphoric. This understanding of how desire is not an on-demand fix is fundamental to understanding how Addyi works for women.
WITW: HSDD is a low-libido condition that affects one in 10 American women. How does the drug target the issues?
CW: We know from multiple brain scan studies that women with Hypoactive Sexual Desire Disorder can show a fundamentally different response to sexual stimuli than women who don’t suffer from the condition. While Addyi’s exact mechanism of action is unknown, we do know it has effects on brain receptors that are known to be involved in sexual excitement or inhibition.
WITW: How does it affect person-to-person? Specifically, who should be interested?
CW: There are clear diagnosis criteria for HSDD. Women can find the diagnostic questionnaire, the Decreased Sexual Desire Screener, on our website at addyi.com and have the discussion with her healthcare provider. In the simplest terms, a woman with HSDD has lost the desire they once knew, that loss has persisted for more than six months, they are bothered by it and want to do something about it. Importantly, their lack of desire is not being caused by other things such as a relationship issue or another medical condition. A different treatment course would be right for those women.
WITW: What do you make of the debate within the medical community about whether HSDD is a legitimate medical condition?
CW: In terms of whether or not this is a medical condition, there is no basis for debate. Hypoactive Sexual Desire Disorder first appeared in the medical literature in 1977 as a medical diagnosis in the DSM and International Classification of Diseases for decades. Those who would question its existence would be out of step with the medical mainstream.
WITW: How do doctors differentiate a disorder from a natural change in desire after a woman has been with the same partner for decades or hasn’t experienced pleasure with sex partners?
CW: These factors are accounted for in the screener used to diagnose Hypoactive Sexual Desire Disorder. If the nature of a woman’s lack of interest in sex is because of her partner, it is not HSDD. Further if a woman hasn’t ever experienced desire before, she would not be a candidate for treatment with Addyi. Women appropriate for treatment have acquired HSDD meaning they have lost a ‘normal’ desire they once knew, that loss has persisted, they are bothered by it and they want to do something about it.
WITW: Could simply being with a different or new partner provide a similar result as Addyi?
CW: HSDD is not partner dependent. Imagine being a woman with this medical condition who deeply loves her partner yet has lost the sexual desire she once knew and simply wants to have that important piece of her relationship back. Now imagine someone telling you to find a new partner. Someone actually said that to the women in the room with HSDD from the public microphone at the FDA workshop just last year. And we wonder why progress in this condition has taken so long.
WITW: Bloomberg reported that Addyi’s interaction with alcohol was tested on far more men than women. Can you explain why a women’s drug would be tested mostly on men?
CW: This requires a little background on the nature of drug development. You complete large pivotal trials looking for benefits and risks to the population you intend to treat. You want those trials of your treatment group to look like the generalizable population. So, with Addyi, in our pivotal trials about 58 percent of the women characterized themselves as mild to moderate drinkers. What you also do is complete ‘challenge’ studies in healthy volunteers (they don’t have the condition as they’re not the intended treatment population) to test the drug under challenge circumstances. So, with Addyi, we also did an alcohol challenge study with specific amounts of consumption in short periods and dosed right after that to test safety. For that particular healthy volunteer study, more men enrolled. Studies continue to happen after approval of drugs and we have a number of alcohol studies we’re working with the FDA on now.
WITW: Have you ever tried using Addyi?
CW:I have not ever used Addyi as I don’t suffer from HSDD. If I ever developed the condition, I can say for certain that I would at least want the choice of medical treatment to talk to my healthcare provider and make the decision for myself.
WITW: Tell us about the process of getting the drug approved and what the challenges were?
CW: For too long in this category progress has been held up because of a strong societal narrative that reduces all things in the bedroom for women to psychology, while believing all things in the bedroom for men are biology. Both genders bring both to the bedroom. Yet women with a biological dysfunction still didn’t have a single medical treatment option. At Sprout, we never accepted that narrative — science told us a different story.
WITW: What does this deal mean to you?
CW: This deal means we have the opportunity to make good on the Sprout mission in an even bigger way now. From the outset, we have always believed that women with this medical condition deserved access to a medical treatment to make the decision for themselves. Now that we have broken through with an approval in the U.S., the global footprint of Valeant could allow us to eventually do the same for women across the world. Right here in the U.S., this deal allows us to offer more affordable access to women than Sprout would have been able to do on its own out of the gate. It is the next phase of the mission to get this right for women.
WITW: What is next for women’s sexual health?
CW: It is my hope that what’s next is an honest conversation about female sexuality — a real shift from all the myths and judgments that hold up progress to a conversation that respects a woman’s experience as well as the scientific evidence that can separate fact from fiction.
WITW: What do you view as the biggest myths and judgments that are holding up progress?
CW: The biggest myth and, frankly, judgment is the one that dismisses the biological basis of sexual desire in women. Can you believe that it’s 38 years after this condition first appeared in the Journal of Sex and Marital Therapy and we’re actually still talking about whether or not this is a legitimate condition and deserves treatment?
WITW: What do you hope changes in society when it comes to women?
CW: Do I only get one answer? If yes, here it is in my world of medicine. It is my hope that when women advocate for themselves they are no longer met with skepticism that would suggest that the listener knows better than the woman herself who is living the experience. I believe in respecting others personal truths and starting our conversations there.