Cindy Whitehead, the woman who spearheaded the successful campaign to win approval for the first prescription drug to treat female sexual dysfunction, says the time has come to stop calling the medication “female Viagra.”
Whitehead delivered this message at the early December conference of Fortune’s Most Powerful Women Next Gen Summit in San Francisco. As it turned out, it was one of Whitehead’s final speeches as the chief executive officer of Sprout Pharmaceuticals, the company behind the new female drug known as Addyi.
Pointing out that Addyi bears little similarity to Viagra, an on-demand drug to combat erectile dysfunction, Whitehead explained that Addyi must be taken on a daily basis for two to four weeks before its effects begin to show up. While Viagra tackles a blood-flow issue, Addyi rejiggers brain chemistry to help fire up the female libido in women suffering from hypoactive sexual disease disorder, or HSDD.
How Addyi Works
Flibanserin, the active ingredient in Addyi, appears to decrease brain levels of serotonin, a neurotransmitter that inhibits sexual desire, while increasing levels of dopamine and norepinephrine, both of which promote sexual desire. It accomplishes that goal by its effects on two serotonin receptors in the brain. Addyi enhances the effects of 5-HT1A, the receptor that puts the brakes on serotonin production, while inhibiting the 5-HT2A receptor, which accelerates serotonin production.
As previously noted, Addyi, unlike Viagra and the other male impotence drugs, must be taken daily to be effective. And any positive effects on a patient’s sex drive probably won’t be seen until the drug has been taken for two to four or more weeks. In this respect, Addyi is more like an antidepressant, which usually takes a few weeks to kick in. Patients who have taken Addyi for six to eight weeks and have not yet seen positive effects are advised to discontinue their use of the medication.
Similar to an Antidepressant
Addyi’s similarities to an antidepressant should come as no great surprise, since flibanserin, its active ingredient, was originally developed as a possible antidepressant. Flibanserin’s original developer was German pharmaceuticals giant Boehringer Ingelheim. After flibanserin failed to make the grade as an antidepressant, Boehringer launched clinical trials of the drug as a treatment for HSDD, the most common form of female sexual dysfunction. In late 2009, Boehringer filed a petition with the FDA seeking the agency’s approval to market flibanserin. On June 18, 2010, an FDA advisory panel voted unanimously to recommend that Boehringer’s petition be rejected. Members of the panel cited the drug’s disappointing risk-benefit ratio, based on the results of clinical trials conducted by Boehringer.
After the FDA advisory panel turned thumbs down on flibanserin, Boehringer decided in October 2010 to cut its losses on the drug and made known its willingness to sell off rights to flibanserin to another company. Convinced of the need for a medication to treat this form of female sexual dysfunction, Cindy and Bob Whitehead, cofounders of Slate Pharmaceuticals, bought the patent to flibanserin in early 2011.
Sprout Founded in Late 2011
In late 2011, Slate was sold off to GTCR/Actient Pharmaceuticals, and the Whiteheads cofounded Sprout to carry on the research and promotion for flibanserin, which they believed could be a godsend for women who had lost their interest in for sex.
It was not an easy job winning FDA approval for flibanserin, which the Whiteheads planned to market under the brand name of Addyi, but the couple kept up the good fight, even in the face of another rejection by an FDA advisory panel. However, in response to Sprout’s request for more guidance, the FDA did offer some fairly specific guidelines about what it needed to see before giving Addyi the green light.
Sprout conducted additional clinical trials and in February 2015 submitted a revised petition seeking FDA approval of the drug. On June 4, 2015, an FDA advisory panel recommended FDA approval of the drug, and on August 18, 2015, the FDA formally approved the marketing of Addyi, albeit with a few strings attached. Addyi officially became available to the public on October 17, 2015.
Whitehead Steps Down
Barely a week after her remarks to the Fortune conference, Whitehead announced that she was stepping down as Sprout’s CEO, a position she’s held since she and her husband, Bob Whitehead, cofounded the company in 2011. Only days after the FDA finally gave the green light to Addyi, Sprout was bought up by Quebec-based Valeant Chemicals. Under the terms of that acquisition North Carolina-based Sprout was to continue operations as a subsidiary of Valeant.
Whitehead’s departure as CEO comes in the wake of reports that Addyi prescriptions numbered only 227 in its first five weeks on the market. However, Whitehead disputed those reports, suggesting that the numbers were somewhat higher than that. She declined to supply hard figures. She told Fortune that as of early December 2015 10,000 medical providers and 30,000 pharmacies had been certified to prescribe and dispense the drug.
Addyi in REMS Program
Addyi’s slow start could in part be attributable to the conditions that the FDA attached to its approval of the drug in August 2015. Because of concerns about the risk of extremely low blood pressure and/or fainting, the drug regulatory agency approved Addyi under its REMS (Risk Evaluation and Management Strategies) program. To prescribe or dispense drugs under the REMS program, medical providers and pharmacists must first take a brief online training course to show that they understand these risks and thus can properly counsel patients interested in taking the drug.
In approving Addyi, the FDA also mandated the inclusion of a boxed warning on the drug’s labels and packaging inserts warning Addyi users to avoid alcohol while taking the prescription drug as the two in combination are more likely to cause loss of consciousness and hypotension.
Time for New Leadership
In the wake of Whitehead’s announcement that she was stepping down, Valeant spokesperson Laurie Little said that Whitehead would continue to serve Sprout as a consultant. Of Whitehead’s departure, Little said, “Having built a team to take Addyi to market, we mutually agreed that it was the right time to transition to new leadership for the next phase of global commercialization.”
Replacing Whitehead as Sprout’s top executives are Tracy Valorie and Ray Larwood of Valeant. About Sprout’s new leaders, Little said, “We look forward to continued progress under the leadership of Tracy Valorie and Ray Larwood, and we are pleased that the team will continue to benefit from Cindy’s guidance as a consultant to Sprout.”
Whitehead’s Parting Message
In a parting message to the staff at Sprout, Whitehead said, in part, “While bittersweet, the truth is phase 1 was mine to shepherd. Phase 2 is yours. What you have already accomplished despite the distractions is a testament to the potential of Addyi and who you are as advocates. You will not compromise in getting this right for women — that’s why you’re here. I’m excited to take my new seat, this time in the front row of the sidelines, cheering you on and marveling as Addyi changes the conversation forever. I’ll be the one in pink.”
To check out additional articles about Addyi, Viagra, and other related medical topics, check out our blog.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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