The third try was the charm. In two previous presentations to the Food and Drug Administration the makers of flibanserin (Addyi) failed to pass muster. But on Thursday afternoon, June 4, 2015, a panel of outside FDA experts recommended by a vote of 18 to 6 that the agency approve the first medication to enhance libido in women.
Your People’s Pharmacy pharmacologist (Joe) spent most of the day watching the live streaming video from FDA’s headquarters in “The Great Room” (Rm. 1503) in Silver Spring, Maryland. The committee room was jammed and the meeting droned on for hours. At times it was downright tedious, but dozens of public presentations from women and physicians enlivened the otherwise dry hearings.
A Quick Overview on Flibanserin
Initially, the big drug company Boehringer Ingelheim was trying to develop flibanserin as a new antidepressant. It failed unequivocally. But the company resurrected the compound to improve libido in women with hypoactive sexual desire disorder (HSDD), also known as low or no libido.
In a 2009 meeting at the FDA, the request for approval to boost sex drive was unanimously rejected. Not long after that setback, Boehringer Ingelheim gave up on flibanserin and a small company in North Carolina, Sprout Pharmaceuticals, obtained the rights to develop the drug. After more clinical trials Sprout showed up on FDA’s doorstep seeking approval and once again (in 2013) received the big rejection notice. Many people assumed that the panel would once again reject the drug in 2015, but this time Sprout got the green light…with caveats.
How Effective Is Flibanserin?
How effective Is flibanserin? Not very. Much of the day at the FDA was spent arguing whether flibanserin works well enough to help women overcome a low or nonexistent sex drive. FDA staffers characterized the drug’s benefits as “numerically small but statistically significant.” What that means is that women taking flibanserin had one more “sexually satisfying event” each month compared to the women taking placebo. There was also a modest increase in feelings of sexual desire.
Many of the committee members and some members of the public who spoke derided this small benefit. Other women insisted that flibanserin made a big difference in their lives and that even a small benefit was better than nothing.
The Politically Correct Controversy
Some of the women who spoke during the public session argued that this was about medicalizing a “normal” situation. The implication was that this was a profit-driven drug company scam to make money. But women representing NOW (the National Organization of Women) spoke out in favor of flibanserin. This is an issue that has deeply divided the women’s movement.
What About Flibanserin Side Effects?
Much of the discussion during the afternoon session was devoted to questions about safety. Flibanserin side effects include dizziness, nausea, drowsiness, low blood pressure and fainting (syncope). Many of the panel members made it seem like these complications were deal busters. Some of the health professionals sitting around the very big table implied that these adverse drug reactions were so serious that they could not bring themselves to vote for approval. In particular, there were extended discussions about an interaction between flibanserin and alcohol. This combination could increase the risk of dizziness and fainting and possibly lead to dangerous falls.
What we find intriguing about the side effect discussion is that so many other drugs are given a green light even though they have far more serious complications. The stop-smoking drug varenicline (Chantix), for example, lists these adverse reactions:
“Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX…Seizures, Interactions with Alcohol, Cardiovascular Events, Angioedema [potentially life threatening], Serious Skin Reactions.”
Other symptoms linked to Chantix include nausea, flatulence, heartburn, insomnia, nightmares, headache, bad taste, dizziness, disorientation, difficulty concentrating, fainting and arthritis, to name just a few.
Watch almost any prescription drug commercial on TV these days and you hear about side effects like dizziness, heart attack, liver damage, weight gain, trouble breathing…and death. FDA officials don’t seem to bat an eye.
Compared to many other prescription drugs, flibanserin doesn’t actually seem that scary.
Is Flibanserin Pink Viagra?
Absolutely not! Although it has been in the headlines as Viagra for women, the drug is totally different from drugs like Viagra or Cialis. Those drugs work through the cardiovascular system. They increase blood flow to the penis and help men achieve an erection. They do NOT increase libido. Flibanserin affects neurotransmitters in the brain to modestly improve libido.
Could flibanserin be turned into a date rape drug or be an aphrodisiac, turning women into nymphomaniacs? Absolutely not! It takes days to weeks for the beneficial effect to show up and even then it is modest at best. Women would not become obsessed with sex because of flibanserin.
The Bottom Line
The FDA expert panel voted to approve flibanserin as a libido enhancer for women with HSDD. That does not mean the Food and Drug Administration will follow the advice of this group of health professionals. It is unlikely that the FDA would ignore their recommendation, but that sometimes happens.
It will be many months before the agency makes up its mind and we learn if flibanserin, under the name Addyi, shows up in the pharmacy. It will be available only by prescription.
The panel did not give the drug a green light without caveats, though. There was a clear message that the FDA needs to manage the drug’s risks. That could mean special warnings and follow up. Keep visiting PeoplesPharmacy.com for the latest updates on flibanserin.