With the FDA’s conditional approval of flibanserin, women now have a drug to help them fire up their libido.For tiny Sprout Pharmaceuticals, it was quite a week! On Tuesday, August 18, 2015, the U.S. Food and Drug Administration gave the company’s only drug a conditional go-ahead, and barely two days later the North Carolina-based company announced that it was being acquired for a cool $1 billion by Valeant. Valeant’s move to acquire Sprout is seen by many observers as a solid vote of confidence in the long-term outlook for flibanserin, the first FDA-approved drug for the treatment of female sexual dysfunction.
Not a bad week at all for a company that didn’t really exist until about five years ago. In fact, Sprout was cofounded by the husband-and-wife team of Cindy and Robert Whitehead for the express purpose of winning FDA approval for a prescription drug that could help women deal with hypoactive sexual desire disorder, or HSDD. The disorder (decreased sexual desire) is the most common form of sexual dysfunction among women. Unlike sexual dysfunction in men, which most often involves blood flow to the genitals, women’s biggest sexual problems can often be traced to an imbalance in brain chemistry.
Prior to founding Sprout, the Whiteheads were both top executives at Slate Pharmaceuticals, which developed and marketed an implantable testosterone replacement therapy system known as Testopel.
Origins of Flibanserin
Flibanserin was first developed by German pharmaceuticals giant Boehringer Ingelheim, which in 2010 submitted a new drug application to the FDA in hopes of marketing the drug as a treatment for HSDD. Later that year, the FDA rejected Boehringer’s application, and not long thereafter the company decided to abandon its campaign on behalf of flibanserin, the patent to which was acquired by Sprout in 2011.
Winning FDA approval for the drug did not come easily, but Sprout proved that it was more than equal to the task despite its relatively small size. Now that the heavy lifting has been done, Valeant Pharmaceuticals has acquired Sprout and Sprout’s biggest asset, flibanserin, which is scheduled to be marketed as Addyi. Current projections indicate it will come to market sometime during the fourth quarter of 2015.
Many Obstacles Overcome
In a recent interview with Business Insider, Cindy Whitehead, Sprout’s chief executive officer, talked frankly about some of the obstacles that had to be overcome to win FDA approval for flibanserin. She also shared her thoughts about the importance of bringing a drug to market that offers hope for women who have lost their interest in and desire for sex.
For women, the most common form of sexual dysfunction is a loss of interest in and desire for sex.“I think the possibility of offering women access to a treatment really meant a lot to me,” Whitehead told Business Insider, noting that since Viagra’s 1998 introduction the FDA has approved 27 drugs for male sexual dysfunction and, until August 18, 2015, none for women.
Unlike Boehringer Ingelheim, which walked away from flibanserin after the FDA’s rejection in the fall of 2010, Sprout refused to give up on the drug. To prepare its application for the drug’s approval, Sprout conducted studies that it hoped would answer some of the safety concerns cited by the FDA in rejecting Boehringer’s application.
Flibanserin Resubmitted in 2013
With the results of those studies accompanying its application, Sprout in June 2013 once again petitioned the drug regulatory agency for permission to market flibanserin. However, the FDA rejected Sprout’s application, again saying that the drug’s risks outweigh its modest benefits and also citing concerns about flibanserin’s long-term effects. The agency also requested an additional study to determine flibanserin’s potential drug interactions with other medications and a driving study to see if flibanserin is likely to cause sleepiness for women behind the wheel.
Still stinging from the FDA’s latest rejection, Sprout in December 2013 appealed the FDA decision and filed a request for a formal dispute resolution with FDA’s Office of New Drugs. In support of Sprout’s appeal, the International Society for the Study of Women’s Sexual Health sent the regulatory agency a petition with 4,000 signatures urging approval of flibanserin. In response, the FDA offered detailed guidelines that Sprout might choose to follow to win approval of the drug.
Proponents, Foes Rally Forces
Much of the spring of 2014 was devoted to a mustering of forces, both pro and con, on the issue of flibanserin. In April, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, received a letter from a group of women’s health organizations urging FDA rejection of the drug on the grounds that its risks outweigh its benefits.
Two months later, with Sprout’s backing, a coalition of 24 women’s and health organizations kicked off the Even the Score campaign, which argued that the drug regulatory agency was guilty of “persistent gender inequality” in terms of treatments for sexual dysfunction. To back up its claim, it noted that the FDA has approved more than 20 drugs to treat sexual dysfunction in men and not a single such drug for women.
Sprout fought long and hard to win FDA approval of flibanserin, a drug designed to treat decreased sexual desire in women.Two-Day FDA Hearing
In October the FDA held a two-day hearing on the unmet need for drugs to treat female sexual dysfunction. Both sides in the continuing debate turned out in force and made known their feelings about gender inequality and whether or not flibanserin should get approval.
In February 2015 Sprout resubmitted its petition for flibanserin approval, including with it details about the results of the additional studies FDA had requested. In early June, an FDA advisory panel voted 18-6 to recommend that the FDA approve flibanserin with conditions. Those conditions would require that prescribers and providers of the drug be certified under the FDA risk evaluation and mitigation strategy (REMS) program and also would require a boxed warning on drug packaging against using the drug concurrently with alcohol or antifungal medications.
Sprout’s Big Week
All of which brings us to Sprout’s big week, which kicked off on August 18, 2015, the last day for FDA action on its advisory panel’s recommendation. As the committee had recommended, the agency approved the drug but only with the conditions the panel had suggested.
On August 20, 2015, in a move that took many observers of the pharmaceuticals industry by surprise, Canada-based Valeant announced its intention to acquire Sprout for roughly $1 billion. While some media observers tried to portray the Whiteheads’ sale to Valeant as a blatant case of “take the money and run,” Cindy Whitehead made clear that she’s not going anywhere. She said she plans to continue to lead Sprout, which will become a division of Valeant if the acquisition goes through. She said she was “very excited to continue working with our 34 employees.”
In announcing plans for the Sprout takeover, Valeant CEO J. Michael Pearson said, “Delivering a first-ever treatment for a commonly reported form of female sexual dysfunction gives us the perfect opportunity to establish a new portfolio of important medications that uniquely impact women.”
Photo credit: Day Donaldson
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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