Women discuss female libido drug trial at G.W.

Lori Lundin, wtop.com

WASHINGTON — Declining hormones and job stress are among the problems that take their toll in the bedroom and on relationships. And while the airwaves are saturated with ads for sexual dysfunction drugs for men, some ask, “Where are the sex drive drugs for women?”

There are 24 FDA-approved treatments for male sexual dysfunction, zero for women. Nearly half of all women will suffer low sex drive at some point in their lives.

“I couldn’t seem to connect with my husband anymore. I had no desire,” says 33- year-old Maryland resident Jane Smith.

“We got to a point where divorce was an option for us.”

But Smith says her doctors seemed to brush off the concerns, telling her it was just stress.

Then Smith heard about a clinical trial at George Washington University for Sprout Pharmaceutical’s little pink pill, called Flibanserin. It’s said to boost desire by raising neurotransmitters in the brain. Smith signed up for the trial and says not only does she feel vindicated – but it worked.

“You’re reminded, you’re still alive … things are still happening down there.”

Amanda, a 50-year-old married mother of two, had similar problems. She enrolled in a year-long trial of Flibanserin in Nashville, Tenn.

“They would sync up my diary and I’d answer questions as to how often I initiated, how often I was aroused.”

She says she also noticed changes.

“Suddenly, for the first time in a long, long time … just thinking about it started the … arousal process.”

Dr. James Simon, the OB-GYN and clinical professor who led a Flibanserin trial at George Washington, says the drug went through 12 years of vigorous trials for safety, side effects and effectiveness.

“Flibanserin’s been studied in about 11,000 women now. That’s about tenfold more than any single trial of any of those 24 medications for men,” says Simon.

He’s perplexed as to why the FDA has continued to deny the drug’s approval.

“The study was supposed to do X, Y and Z and the drug did X, Y and Z. And yet the FDA seems reluctant to approve the product even though all of the T’s were crossed and the I’s were dotted.”

The FDA is concerned about Flibanserin’s side effects, which include dizzyness, nausea and fatigue, outweigh the benefits. It sees the benefits as modest.

“My question would be, modest by whose definition?” asks Sprout CEO Cindy Whitehead.

She argues that while the FDA finds the benefits modest, the women say it helped them.

“If what we’re saying is that Flibanserin doesn’t make women hypersexual – well, that’s true. It doesn’t. But that would never be the goal of treatment.”

She compares the drug with anti-depressants which aren’t intended to make people euphoric. For now, Smith and Amanda say they’re back to square one.

“Since I’ve been off it, I’ve been searching and there’s just no options for women,” says Amanda.

The ruling is under appeal, but Dr. Leonore Tflier, a sex therapist and clinical professor of psychiatry at New York University, doesn’t think the trials have made the case for FDA approval.

“The reason the FDA didn’t approve it is not because they’re pro-male or out to lunch … it’s because there are side effects and it’s not very effective when compared to the placebo.”

Tliefer says with the female sex drive, there’s no way to define normal.

“All of the clinical research shows a very high and unusually long-lasting placebo effect. You can always find a few people who benefited. The question is, who has the right to draw the line as to when it becomes a medical condition and warrants drug approval?”

But the bottom line, according to Whitehead, is: “It’s been 16 years since the approval of Viagra … but I guess the question is, are we going to let it be two decades before we get a treatment for the most common form of female sexual dysfunction?”

The FDA has requested that Sprout complete two small additional drug interaction studies and a driving simulator study. The company says it will move forward to complete these new studies and resubmit the application for approval of Flibanserin.

Editor’s note: Jane Smith’s name was changed to protect her privacy. Amanda didn’t want to use her last name.

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