The controversial pill flibanserin – purported to be the first treatment for low libido in women – has been recommended for Food and Drug Administration approval by an advisory committee. Previously, advisory committees have twice voted against approving the drug – dubbed by some to be “the female Viagra” – due to safety and efficacy concerns.
Yesterday, we took an in-depth look at the fierce debate that has erupted over flibanserin, which Food and Drug Administration (FDA) advisory committees turned away in 2010 and 2013, prompting a large, well-funded lobbying campaign.
On Thursday evening, the FDA advisers voted 18-6 in favor of flibanserin, but the approval came with a condition that manufacturer Sprout Pharmaceuticals address the safety risks – which reportedly include side effects such as fatigue, low blood pressure and fainting – that have dogged the company’s previous attempts to secure FDA backing.
Susan Scanlan, chair of the pro-flibanserin pressure group Even the Score, welcomed the decision to recommend FDA approval of what the group say as is the first-ever medical treatment option “for women’s most common sexual dysfunction, hypoactive sexual desire disorder (HSDD).”
Scanlan claims that the recommendation has “historic repercussions” for “the 1 in 10 women who are living with HSDD without a single approved medical treatment for their condition.”
As we reported in our Spotlight feature yesterday, critics of flibanserin are skeptical of the 1 in 10 figure, which has become a tenet in lobbying for the drug. HSDD is also a contentious illness – it was removed from the American Psychiatric Association’s Diagnostic and Statistical Manual of Disorders in 2013.
Scanlan rejects suggestions that the results of flibanserin’s clinical trials – which saw 14% of participants drop out due to adverse effects – illustrate the drug is unsafe:
“The science is clear on flibanserin. It has been tested in more than 11,000 women – making it one of the most studied women’s health products in history; its safety is well characterized, as the most common side effects include dizziness, sleepiness and nausea; and the women in the trials themselves said the effects were ‘meaningful’ using the scientific tool that the FDA required.”
The committee heard from more than 30 public speakers – including participants in flibanserin’s clinical trials – who urged the committee to recommend the drug for approval.
Also speaking before the committee on Thursday, Dr. Adriane Fugh-Berman, of Georgetown University in Washington, DC, and director of PharmedOut – a group that investigates the influence of drug companies on medical practice – urged against recommending flibanserin for approval: “To approve this drug will set the worst kind of precedent – that companies that spend enough money can force the FDA to approve useless or dangerous drugs.”
Why has a drug that was previously unanimously rejected by FDA advisory committees now been green-lit? Sprout CEO Cindy Whitehead claims it is because change in the debate is now “really putting the patient voice at the center of it.”
The New York Times report that several committee members voted “yes,” but did so with misgivings because of the low efficacy of the drug reported in trials and its potential side effects.
The paper quoted Tobias Gerhard, a committee member and expert on drug safety at Rutgers University in New Jersey, who reckoned that “the unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point.”
“These are very modest results,” Dr. Julia Heiman, of the Kinsey Institute at Indiana University, told Associated Press. “But on the other hand, even modest results can make a lot of difference when you’re at a certain point in the clinical problem.”
The drug could be approved by August 18th if the FDA follows the recommendation of its advisory committee, which it typically does regarding drug approvals. Sprout have agreed not to advertise flibanserin on television and radio for 18 months, to prevent an initial rush for patients to use the drug.