The controversial ‘female Viagra’ is approved by the FDA. This low libido treatment was twice voted against by advisory committees because of safety and efficacy concerns.
FDA advisers have finally recommended approval of the drug called flibanserin. The drug made by the company Sprout Pharmaceutical was approved under the condition that they fix the health risks, which include fatigue, low blood pressure, and fainting.
Susan Scanlan, the chairwoman of the group Even The Score (pro-flibanserin group) welcomed the FDA’s approval of what the group says is the first ever medical treatment for “women’s most common sexual dysfunction, hypoactive sexual desire disorder (HSDD).”
Scanlan believes that the FDA’s approval has “historic repercussions” for “the 1 in 10 women who are living with HSDD without a single approved medical treatment for their condition.”
Scanlan rejects the notion that flibanserin may be 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 FDA advisory committee heard from 30 public speakers, including women who participated in flibanserin’s clinical trials. The committee voted 18-6 in favor of recommending the drug for approval.
However, not all experts agreed on the approval of this drug. Dr. Adriane Fugh-Berman, of Georgetown University in Washington, DC, and director of PharmedOut, urged against approving this drug: “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,” he said.
Sprout Pharmaceutical’s flibanserin is the first of its kind. It does not work like Viagra does, by increasing blood flow to male sex organs. As written in an article from USA Today: “There has never been a drug before to directly target libido. Flibanserin is the first, and its long term side effects are not yet known. On the other hand, there are already many drugs on the market which target the chemicals of the brain and increase these same brain hormones.”
The drug could be approved by August 18th of this year, if the FDA follows the recommendation of its advisory committee, which they usually do when it comes to drug approval recommendations. Flibanserin will be marketed under the name Addyi.
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REFERENCES:
1. “Controversial Female Libido Pill Backed by FDA Advisory Committee.” Medical News Today. MediLexicon International, 5 June 2015. Web. 09 June 2015.
2. “‘Female Viagra’ Rocks: Finally, Women Get Their Own Little Blue Pill.” USA Today. Gannett, 09 June 2015. Web. 09 June 2015.
3. “Sprout Pharmaceuticals Receives Clear Guidance from FDA on Path Forward to Resubmit New Drug Application for Flibanserin.” Sprout Pharmaceuticals Inc. Sprout Pharmaceuticals Inc, 11 Feb. 2014. Web. 09 June 2015.
4. “Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) and the Drug Safety and Risk Management (DSaRM) Advisory Committee.” FDA. FDA, 4 June 2015. Web. 9 June 2015.
