August 19, 2015 — FDA on Tuesday approved Addyi, the first medication to treat female sexual dysfunction, AP/Modern Healthcare reports (AP/Modern Healthcare, 8/18).
FDA has rejected flibanserin -- brand name Addyi -- twice. In 2010, FDA concluded that the drug was not adequately effective, and, in 2013, it said the drug showed only "modest" benefits in treating female sexual dysfunction (FSD).
Meanwhile, FDA has said there are currently 21 medications on the market that contain estrogen and aim to treat pain during sexual intercourse, as well as vaginal dryness stemming from menopause. Further, in October 2014, some health experts at an FDA workshop on sexual dysfunction drugs questioned whether a drug is appropriate or even possible to address FSD.
In June, an FDA panel recommended approval for flibanserin, a once-daily drug for premenopausal women with FSD not caused by factors such as disease or relationship issues, as long as specific steps are taken to curb risks associated with the treatment. For example, physicians might be required to tell patients about possible side effects -- including dizziness, fainting, low blood pressure and nausea -- and be certified to prescribe flibanserin. In addition, some panelists urged that flibanserin include a warning that users should not take the drug with alcohol or several other medications.
The panel also called on the drug's manufacturer, Sprout, to inform health care providers about the drug's risks and conduct follow-up studies. Specifically, the studies must assess the drug's potential effects when interacting with other drugs and whether it impairs individuals' ability to drive.
Meanwhile, in addition to concerns about the drug's potential risks, the panel noted that studies provided by Sprout measured women's increase in sexual desire on a monthly basis, rather than daily. Further, the panel noted that while the drug was associated with a statistically significant improvement in the number of satisfying sexual events experienced by women, the increase was modest (Women's Health Policy Report, 6/8).
FDA Approves Drug With Restrictions
On Tuesday, FDA approved the drug with several safety requirements.
According to FDA, the drug must be packaged with a boxed warning that highlights risks of low blood pressure and fainting in patients who consume alcohol while taking the medication (Schulte/Dennis, Washington Post, 8/18). The label also must warn that the drug cannot be taken by women with liver impairment or those who are taking certain other medications (Pollack, New York Times, 8/18). According to AP/Modern Healthcare, a boxed warning is the most serious type of warning FDA can require.
In addition, FDA said providers only can prescribe the drug after completing an online training course, that involves informing patients about the drug's risks. Pharmacists also will have to be certified and will be required to tell patients not to drink alcohol while on the drug (AP/Modern Healthcare, 8/18). According to the Washington Post, Sprout CEO Cindy Whitehead said the company has developed an online training course for providers who wish to prescribe the medication.
Meanwhile, FDA also is requiring Sprout to conduct three studies in women to further gauge the severity of the known risks associated with Addyi's interaction with alcohol. Further, FDA recommended women stop taking the medication if they do not see improvement in libido after eight weeks.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies," adding, "Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment."
Sprout Schedules Market Release
Whitehead said the drug would be available as early as Oct. 17. However, she noted Sprout would not directly advertise to consumers for 18 months to avoid creating intense demand for the medication (Washington Post, 8/18).
According to Sprout's estimates, the potential market for Addyi is about 16 million women (Dennis/Schulte, "To Your Health," Washington Post, 8/18). Sprout will focus on marketing Addyi to providers, particularly obstetricians and gynecologists.
A price has not yet been set for Addyi, but it likely will be equivalent to monthly costs for pills that treat erectile dysfunction, the Times reports. Whitehead said she expects many insurers will cover Addyi with monthly copayments of about $30 to $75. She added that Sprout would offer copay assistance for certain patients (New York Times, 8/18).
Whitehead called the drug's approval "a milestone moment to celebrate" that is "game-changing for women."
Likewise, supporters of the drug cited its approval as an end to gender bias at FDA and said the move would allow women to have more control over and choice in their sexual lives (Washington Post, 8/18). Sally Greenberg, executive director of the National Consumers League, called the approval "the biggest breakthrough for women's sexual health since the [birth control] pill" (New York Times, 8/18).
However, critics of the drug questioned its safety and effectiveness. Adriane Fugh-Berman -- director of PharmedOut, an advocacy group focused on drug marketing -- said, "The FDA turned down this drug twice because the risks outweighed the benefits." She added that Addyi's approval "opens the way for drug companies to pressure the FDA through public relations campaigns to approve more bad drugs" (Washington Post, 8/18).
Similarly, Cynthia Pearson, executive director of the National Women's Health Network, said while "a lack of sexual desire can be a distressing problem for women ... women must be able to rely on the FDA to ensure that any drugs or devices marketed to and used by them are both safe and effective." She said, "Despite the FDA's approval" of Addyi, NWHN "still ha[s] serious doubts about whether women are able to make informed decisions about the safety and effectiveness of this controversial drug" (NWHN release, 8/19).
Meanwhile, other observers said Addyi's approval could help clear the path for more FSD treatments. For example, Carl Spana, president and CEO at Palatin Technologies, said his company hopes to submit an FSD treatment for approval in 2017 (Washington Post, 8/18).