Addyi, the much-touted drug said to fire up the female libido, has thus far failed to live up to its advance notices. In mid-March, Michael Pearson, outgoing chief executive officer of Valeant Pharmaceuticals, announced that Addyi’s 2016 sales will almost certainly miss the company’s target of $100-150 million. And if the drug’s early performance is any indication, Addyi’s sales since it went on the market in October 2015 are running at an annual rate of about $11 million, far below Valeant’s target.
Less than 48 hours after the Food and Drug Administration gave its conditional approval to the drug in August 2015, Valeant shelled out $1 billion to acquire Sprout Pharmaceuticals, the North Carolina-based company that fought so hard to get Addyi approved. At the time, the Quebec-based pharmaceutical company expressed optimism that Sprout’s Addyi would be a profitable addition to its product line.
Women’s Groups Demand Action
In the push to win FDA approval for flibanserin, the active ingredient in Addyi, Sprout enlisted the support of women’s groups, many of which expressed outrage at the absence of any female equivalent to the numerous drugs approved to treat male sexual dysfunction. Most suggested that a drug to treat hypoactive sexual desire disorder or HSDD, the most common form of female dysfunction, was long overdue.
At the same time, other women’s groups and individuals argued with equal conviction that flibanserin’s adverse side effects far outweigh whatever meager benefits the drug offers. Such side effects include dizziness, drowsiness, fainting, low blood pressure, and nausea.
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Also concerned about Addyi’s potential side effects, the FDA approved the drug under its REMS (risk evaluation and mitigation strategies) program. Physicians and pharmacists who seek to prescribe or dispense REMS drugs must first take brief online training courses designed to acquaint them with the drugs’ possible dangers. The FDA was also worried about the danger of using alcohol while taking Addyi and thus conditioned its approval of the drug on the inclusion of a boxed warning about such interactions.
It might be argued that the conditions FDA attached to the marketing of Addyi have scared off some potential buyers or at least made them hesitant to try the drug until they’ve seen how others respond to the drug and tolerate its side effects, if any.
However, Addyi also has encountered some other headwinds in its campaign to attract new users, not the least of which came in the form of a recent analysis of clinical data that suggests that Addyi’s benefits are even less than originally claimed. That report, published in the February 29, 2016, issue of the “Journal of the American Medical Association,” found that flibanserin users experienced only one added satisfying sexual event every two months, or one-half an added SSE per month.
Addyi Must Be Taken Daily
Stacked against its possible side effects and the need to completely abstain from alcohol while using Addyi, those very modest benefits may well be too little to persuade women to use the drug. It should also be noted that unlike the male erectile dysfunction drugs with which it is sometimes compared, Addyi must be taken daily to produce results. And a woman may have to take the drug for a few weeks before seeing any results at all. By contrast, the ED drugs are taken only as needed and usually yield results within 30 to 60 minutes after they’re taken.
While headline writers and others have sometimes described Addyi as “female Viagra” or “pink Viagra,” such terminology is confusing and inaccurate. Viagra and the other ED drugs temporarily improve blood flow to facilitate erectile function. Addyi works on brain chemistry in an attempt to increase female sexual desire. In this respect, it is probably more akin to an antidepressant than to an ED drug.
First Tested as Antidepressant
In fact, flibanserin was originally developed by German drugmaker Boehringer Ingelheim as an antidepressant. However, during clinical trials it failed to do much to relieve depression but was observed to somewhat improve sexual health outcomes in women. Boehringer then decided to pursue approval of the drug as a treatment for HSDD. However, the German pharmaceutical giant’s attempt to win FDA approval for the drug failed in 2010 when the U.S. regulatory agency rejected flibanserin.
Shortly thereafter, Boehringer announced that it was no longer planning to seek approval for flibanserin, and in 2011 the company’s patent on the drug was sold to Sprout, a North Carolina start-up founded expressly for the promotion of the drug. What followed was a long fight to win approval for the drug, touted by one of its proponents as “the most important advancement in female sexual health since the [birth control] pill was approved in 1960.” Sheryl Kingsberg, Ph.D., a professor of reproductive biology at Case Western Reserve University’s School of Medicine in Cleveland, used those words to describe the drug at the time it finally won FDA approval.
Sprout’s First Petition Rejected
However, Sprout’s efforts to get the drug approved got off to a somewhat shaky start. After conducting additional clinical trials addressing some of the questions raised about the drug when Boehringer sought approval, Sprout in June 2013 submitted a revised petition seeking FDA approval of flibanserin. Not long thereafter, the FDA once again rejected the drug, saying that its potential adverse effects still outweighed its benefits.
In December 2013, Sprout appealed FDA’s rejection of flibanserin and received in return some suggested guidelines for further testing that the regulatory agency suggested might be enough to win approval of the drug. Somewhat heartened by receiving what it perceived as a road map to approval, Sprout conducted additional clinical trials and in February 2015 once again submitted a revised petition for flibanserin approval.
In early June 2015, an FDA advisory panel voted 18 to 6 to recommend that the agency approve flibanserin. Roughly two and a half months later, on August 18, 2015, the FDA did just that, albeit with the conditions already discussed. Two days after Sprout got approval for Addyi, Valeant bought the smaller company and announced that it planned to begin marketing the drug in October 2015.
Among the bad news that may have slowed Addyi sales in its first months on the market was a report revealing that the drug’s effects when used with alcohol were tested primarily on men, ostensibly because few women volunteered for such a study. In fact, the clinical trial exploring the interactions of flibanserin and alcohol enrolled 23 men and only two women.
‘Through the Looking Glass’
Among those stunned by the revelation of the makeup of the alcohol-flibanserin study group was Carolyn M. Mazure, Ph.D., director of women’s health research at Yale University. “Once again we are through the looking glass,” said Mazure. She went on to say that she could see “no valid reason to ignore the well-established biological and behavioral differences between men and women when conducting biomedical research. Yet it continues to happen.”
While it’s possible that a growing body of positive experiential feedback will in time give a lift to Addyi’s sales, it appears for now at least as though demand for the drug will continue to be sluggish in the short-term future.
If you’d like to read more about Addyi, female sexual dysfunction, and related issues of interest to health consumers, 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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