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Raleigh’s Sprout Pharmaceuticals awaits FDA ruling on female libido drug

Cindy Whitehead, CEO of Sprout Pharmaceuticals in Raleigh holds placebo examples of her company's ADDYI (flibanserin) pink pills Wednesday, August 5, 2015. Sprout may become the first to market the pill for women with hypoactive sexual desire disorder. Sprout has completed its latest round of trials and is awaiting a ruling by the US FDA (Food and Drug Administration) on whether Sprout can take the pill to market.
Cindy Whitehead, CEO of Sprout Pharmaceuticals in Raleigh holds placebo examples of her company's ADDYI (flibanserin) pink pills Wednesday, August 5, 2015. Sprout may become the first to market the pill for women with hypoactive sexual desire disorder. Sprout has completed its latest round of trials and is awaiting a ruling by the US FDA (Food and Drug Administration) on whether Sprout can take the pill to market. hlynch@newsobserver.com

Sprout Pharmaceuticals is a small drug company with a potentially very big drug – the world’s first pill to boost women’s sex drive.

The Food and Drug Administration is expected to announce Tuesday whether it has approved Sprout’s drug, Addyi, which the company plans to market as the “little pink pill.” The agency has rejected the drug twice in the past five years because of questions about its safety and effectiveness.

Interest in Sprout’s libido pill is expected to run so high that, to curb potential misuse, Sprout has promised the FDA it won’t advertise the drug for 18 months on TV and radio.

The drug agency’s decision will cap an unusual media offensive conducted by advocacy organizations during the past year and a half. After several dozen groups – including the National Organization for Women and National Consumers League – lobbed accusations of gender bias and paternalism against the agency, an FDA advisory panel in June recommended that the FDA reverse course and approve the drug.

Anticipation about the FDA ruling is evident in Sprout’s 10th-floor suite on Six Forks Road where a pink theme prevails, from the pink molded chairs to pink gum balls. Colorful wall boards trace the drug’s chronology from its German origins as an experimental anti-depressant through its evolution into a libido pill.

Addyi (pronounced “addie”) is “our representation of Everywoman,” Sprout CEO Cindy Whitehead said of the pill’s brand name. “We hope to do something that really is a game-changer for women.”

If the drug is approved, Whitehead predicts Sprout, which has 31 employees, will “quadruple in size” by hiring drug sales reps to promote the pill to doctors who would prescribe it. Sprout has the ability to ramp up production quickly at facilities in Virginia and Georgia so that it can get the pills to patients this year, she said.

$2 billion estimated market for female libido drugs

Whitehead expects an Addyi prescription will cost between $30 and $75 a month for women who have health insurance, with the insurer covering the rest, based on policies that cover Viagra, the drug prescribed for men with erectile dysfunction.

Sprout also plans to reduce patients’ out-of-pocket costs with a copay assistance program when the drug is launched. The company, founded in 2011, has raised $100 million from more than 100 private investors, Whitehead said.

The potential U.S. annual sales for female libido drugs is estimated at $2 billion, but it’s not clear what slice of that market Sprout would capture. Sprout is seeking FDA approval for its drug to be prescribed to pre-menopausal women with a medical diagnosis, based on a questionnaire and defined by low sex drive and accompanying distress.

The company estimates that 3 out of 10 women in this country have low sex drive, but only 1 out of 10 has the condition accompanied by distress, a potential U.S. market of about 16 million women. Sprout estimates it will have 11 years of exclusivity on Addyi before the patent expires and generics become available, Whitehead said.

Whitehead assures that Addyi is not meant to be prescribed to women looking for a little extra pizazz or women who are bored with their husbands.

“It’s not some magic pill,” Whitehead insists. “It’s not going to fix relationships.”

Path to libido drug

Sprout’s pink pill has earned the startup plaudits as a liberating force for women and condemnation from critics who say the company is exploiting female sexual insecurities. Some of the nation’s leading women’s rights organizations and medical experts have come down on opposite sides.

“It’s a symptom of the times in which we live as a very affluent society,” said John Thorp Jr., a UNC-Chapel Hill gynecology professor. “Big Pharma, in return for our money, will offer us that illusion.”

Thorp, UNC’s division director for Women’s Primary Healthcare and vice chair for research, tested the libido drug in clinical trials about five years ago when it was owned by German drug developer Boehringer Ingelheim; he remains ambivalent about flibanserin, which is the active drug in Addyi.

Thorp said it’s not always clear whether loss of sexual interest is a disorder or a normal function of aging. Unlike a drug for men like Viagra, which increases blood flow, flibanserin works on the frontal cortex and influences brain chemistry by adjusting levels of the neurotransmitters dopamine, serotonin and norepinephrine.

Is this really what the world needs? Will this make people healthier and happier? I have my doubts.

John Thorp Jr., UNC-Chapel Hill gynecology professor

Viagra is taken as needed and takes effect within an hour, whereas Addyi would have to be taken every day and could take several weeks to become effective.

“I admire Sprout for pulling it out of the fire. I’d love for a North Carolina company to make a lot of money,” Thorp said. “But is this really what the world needs? Will this make people healthier and happier? I have my doubts.”

The drug has been developed in consultation with impotence specialist Irwin Goldstein, who gained prominence after testing Viagra for pharmaceutical giant Pfizer in the 1990s. Goldstein was also an adviser to Boehringer Ingelheim on flibanserin research. The German company initially developed flibanserin as an anti-depressant but switched it to a sex drive treatment when patients in clinical trials began reporting improved sexual desire.

If flibanserin had been approved in 2010 for women, Goldstein was to have been Boehringer Ingelheim’s principal investigator for developing the libido pill for men, “because there is no reason it shouldn’t work in the other gender,” he said.

When the FDA rejected flibanserin, the Germans backed out of the project and put flibanserin out for bid. Shortly thereafter, Goldstein, now medical director of sexual medicine at Alvarado Hospital in San Diego, introduced flibanserin to pharmaceutical executives Cindy and Bob Whitehead. At the time, the Whiteheads ran Slate, a Durham company that acquired the rights to flibanserin. They renamed the company, which had moved to Raleigh, Sprout in 2011. Goldstein remains a paid consultant on Sprout’s advisory board.

Slate had produced a testosterone pellet called Testopel that in 2010 earned a warning letter from the FDA for exaggerated marketing claims. The FDA said Slate’s Web pages and videos misleadingly suggested the drug could improve mood, increase sexual interest and restore erectile function. In one promotional video, a doctor was quoted as saying: “They start chasing their wives around the room a little bit – they just feel like guys again.”

Cindy Whitehead said Slate complied with the FDA’s demands and pulled the offending ads.

Whitehead – who has experience in pharmaceutical sales, corporate branding and beauty products at companies ranging from Merck to QVC – said a big part of her job at Sprout has been disabusing people of misconceptions about female sexual interest and arousal disorder.

“I’m asked those questions all the time: ‘What if Brad Pitt walked into the room?’ It doesn’t make any difference,” Whitehead said. “The patient lost it. It’s been gone for some time. And, frankly, they just want it back.”

Safety concerns

For the FDA, the issue remains whether the drug’s incremental boost in sexual desire, which is small but statistically significant, outweighs the risks of dizziness, sleepiness and fainting that the drug can induce in some women. Pressure on the agency intensified in late 2013 when activists took up the cause of flibanserin, writing letters to Congress, meeting with the FDA, and lining up dozens of women (and their husbands) to testify in support of the drug.

The movement, calling itself Even the Score, included national groups as well as Durham-based American Sexual Health Association. It also included a number of paid consultants for Sprout, including former FDA women’s health director Audrey Sheppard and University of Virginia psychiatrist Anita Clayton.

They were motivated by the availability of Viagra and other libido drugs for men but no products for women to treat low sex drive.

A woman who’s not had a healthy sexual relationship with her partner might be willing to be a little sleepy to address that.

Deborah Arrindell, vice president of health policy, American Sexual Health Association

“It’s one of those cases where women vote with their libidos,” said Deborah Arrindell, vice president of health policy for the American Sexual Health Association. “A woman who’s not had a healthy sexual relationship with her partner might be willing to be a little sleepy to address that.”

Many of Sprout’s supporters say they were unaware there was an issue with loss of sex drive for women until they were introduced to women struggling with the problem.

“It’s a real condition,” said Sally Greenberg, executive director of the National Consumers League in Washington. “We were hearing stories of women who were going to commit suicide, women telling their husbands to have affairs.”

In op-ed pieces, letters to Congress and on social media, Sprout has become a litmus test on gender politics, a symbol of a pill-popping society, and a declaration of sexual pleasure as a basic human right. As Even the Score gained momentum, a countermovement – consisting of groups such as the National Women’s Health Network, Our Bodies Ourselves and the National Center for Health Research – coalesced to oppose the flibanserin campaign.

“We made it clear all along that we were not impressed with the data,” said Diana Zuckerman, president for the National Center for Health Research. “The last thing I want to see is the FDA getting politically pummeled for making a scientifically appropriate decision and then reversing themselves.”

The FDA advisory panel approved Sprout’s drug 18-6 on the condition that Sprout include risk mitigation measures – such as warnings and restrictions – to prevent misuse of the drug. “These members also noted the marginal efficacy and significant safety concerns but took into account the unmet medical need,” according to the session minutes.

If the FDA overrules its advisory panel and rejects flibanserin again, Sprout plans to focus on getting Addyi approved in Canada and Europe, Whitehead said.

Having tasted success, Even the Score would likely continue its campaign at the FDA. Greenberg said not approving it is unwise health care policy because it inadvertently promotes under-the-counter remedies that have not been tested for safety or effectiveness.

“We want women to have the same kinds of options men have,” she said.

John Murawski: 919-829-8932, @johnmurawski

Addyi at a glance

▪ Unlike Viagra, which increases blood flow for men, Addyi influences brain chemistry.

▪ It has to be taken every day and could take several weeks to become effective.

▪ It’s not a miracle drug. Clinical trials showed a modest – though statistically significant – change in sexual desire.

▪ There are safety concerns. Among the side effects are fainting, nausea and low blood pressure. Expect it to come with a host of safety warnings.

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