After filling out a questionnaire, Parrish found out she had symptoms of HSDD and was selected to participate in the Flibanserin clinical trials. She had to take the pills every day and keep a diary of her progress.
“The diary was very personal,” Parrish said. “Every morning it would go off and I would have to answer if I had sex, if I had initiated sex, if I had turned it down, if I had lubricated, if I had orgasmed. ... Within a couple weeks I began to notice a dramatic difference in the way I responded.”
Over 1,000 women participated in Sprout’s key clinical trial. According to Sprout Pharmaceutical’s results, on average, women taking Flibanserin doubled their number of so-called “satisfying sexual events” with taking the drug, and reported a 50 percent increase in sexual desire.
But about 15 percent of those women in the clinical trials dropped out because of side effects, including sleepiness, dizziness and anxiety, which Flibanserin proponents point out seem mild compared to the side effects listed in the now iconic Viagra commercials, such as nausea, diarrhea and the risk of erections lasting over four hours.
The FDA last rejected Flibanserin in December 2013, though Whitehead and Sprout Pharmaceuticals are appealing the FDA’s decision.
“We heard from the FDA in the simplest term, ‘no,’” Whitehead said. “What they basically said to us is in the risk-benefit evaluation. They felt that Flibanserin's effect was only modest, and, therefore, they didn't give us an approval.”
The FDA’s rejection of Flibanserin ignited a storm of controversy with many crying sexism. The government agency was bombarded with letters in support of the drug from prominent women’s groups and even a handful of congresswomen.
“There’s absolutely some sexism at play,” Streicher said. “No one is making this up. This is not a hallmark holiday that someone just decided to invent something in order to sell more of something.”
The FDA declined “Nightline’s” request for an interview about Flibanserin and declined to comment on the drug, but said in a statement that they are, “committed to supporting the development of therapies for medical conditions related to female sexual dysfunction” and denied allegations of gender bias. Read the FDA's full statement here.
Some doctors believe Flibanserin was rejected for a very simple reason: it’s an ineffective drug for a non-existent problem.
Dr. Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center (GUMC), is also the director of the medical center’s research project PharmedOut, which analyzes the effects of pharmaceutical marketing on prescribing practices. She said the buzz created around Flibanserin is a “classic marketing technique” for new drugs.
“It’s not sexist for the FDA not to approve a drug that it doesn’t believe is effective or safe,” Fugh-Berman said. “It’s a classic marketing technique to first create a problem, and then sell the solution, and that’s what’s going on here,”
“Of course sexual desire varies by person and it varies by phase of life, but that doesn’t make it a disease,” she continued. “This is a drug with minimal effectiveness, if any, and it’s meant to be taken every day for a condition that is not of a disease.”
At the FDA’s request, Sprout Pharmaceuticals is running two more trials on Flibanserin before the agency brings it up for review again. If Sprout wins the appeal, Flibanserin could be available with a prescription as early as next year.
“I will be the first one waiting for my prescription,” Parrish said. “I believe that strongly in how it works and that women deserve an equal opportunity to enjoy and become equal members in their sex life as men have become with the products available.”