Sally Greenberg of the National Consumer's League acknowledged the drug's potential impact, “This is the biggest breakthrough for women’s sexual health since the pill.”
Leah Millheiser, director of the Female Sexual Medical Program at Stanford University School of Medicine, supports the diagnosis of HSDD and Addyi for its treatment: "HSDD is a very real problem for women." Millheiser appears to be convinced the disorder is due to a neurotransmitter imbalance, and according to her, “the data [presumably from outcome studies] showed that true responders had six to eight additional sexual events per month” after using Addyi.
Indeed, Addyi seeks to reorder cerebral cortex (brain) chemistry. “Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist,” the FDA explains. The goal with flibanserin seems to be elevating mood to increase sexual appetite. However, the FDA admittedly doesn't know why the once-daily pill improves sexual dysfunction.
Results on the efficacy of flibanserin come from very few studies. Statistical differences, while considered to be scientifically significant, show minimal appreciable gains for sexual satisfaction and offer non-specific information on the medication's benefits. As with other medications that are thought to alter neurotransmitter functioning, any chemical reactions flibanserin may have are not well understood.
Criticism for Addyi
When the FDA rejected Addyi the first time in October 2014, the outcry from women everywhere was loud and clear, including those in the pharmaceutical industry, women's rights groups and even female Congresswomen. Cindy Whitehead, Sprout's COO, criticized the numerous low testosterone and erectile dysfunction drugs for men – 24 compared with zero for women -- implying the FDA was sexist. Reps. Debbie Wasserman Schultz, Chellie Pingree, Nita Lowey and Louise Slaughter penned a joint letter to FDA Commissioner Margaret Hamburg asking the organization to apply "the same standards of consideration given to the approved drugs for men in your risk/benefit evaluation."