1st pill aimed at boosting female libido OK’d Q&A: 1st pill approved to boost female sex drive
The U.S. Food and Drug Administration (FDA) has approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s.
The drug’s label will bear a boxed warning — the most serious type — alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol. The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr. Janet Woodcock, director of the FDA’s drug center, in a statement announcing the approval Tuesday.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counseling patients about Addyi’s risks. Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.
Opponents of the drug say it’s not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.
“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.
Patients should stop taking the drug after eight weeks if they do not see any improvement, notes the FDA release.
Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lackluster effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
On one side, Sprout and its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug’s launch in mid-October, doctors who see patients complaining about a loss of sexual appetite will have a new option.
“Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr. Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists. Iglesia said she has occasionally resorted to prescribing testosterone creams to boost women’s libido, a use not approved by the FDA.
The search for a pill to treat women’s sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological
U.S. federal health officials on Tuesday approved the first-ever prescription drug intended to treat women suffering from a lack of sexual desire, ending a vigorous debate over the drug’s fate.
The daily pill, called Addyi, comes with warnings about risks of fainting if it is combined with certain other drugs or alcohol. Additionally, doctors won’t be able to prescribe it unless they complete an online certification test.
Here’s a look at the new drug from Sprout Pharmaceuticals:
How Does It Work?
Addyi, known generically as flibanserin, acts on brain chemicals associated with mood and appetite, similar to antidepressant drugs. In fact, it was originally studied as a treatment for depression before being repurposed into a libido drug. It’s not entirely clear why the drug increases sexual desire but researchers point to its ability to increase dopamine — a brain chemical associated with appetite — while lowering serotonin — another chemical linked with feelings of satiation.
Who Will Take This Drug?
The U.S. Food and Drug Administration (FDA) approved Addyi functions all proved ineffective.
Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite.
Women and their doctors will have to decide whether the drug’s modest benefits warrant taking a psychiatric pill on a daily basis. for premenopausal women with hypoactive sexual desire disorder, described as a lack of sexual appetite that causes emotional distress.
Surveys estimate that between 5.5 million to 8.6 million U.S. women have the condition, or roughly 8 to 14 percent of women ages 20 to 49. Because so many other factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship problems, medical conditions and mood issues caused by other medications like sleeping aids and painkillers.
The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.
I’ve Heard This Decision Was
The drug followed a long, contentious path to approval, including two previous rejections by the FDA. For years, two opposing sides have argued over the fate of the drug.
On one hand, drugmakers and some medical experts argue that women need FDA-approved medications to treat sexual disorders, which they consider serious medical problems. On the other side,
Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.
Tiefer and other critics said the FDA was pressured into approving the drug by a feminist-themed lobbying campaign funded by Sprout consumer-safety advocates have said the drug’s side effects are too risky, and there are those who question whether low libido is a medical condition.
On top of this debate, Sprout Pharmaceuticals enlisted outside politicians and women’s groups to lobby the FDA to approve the drug.
Does the Drug Work?
Experts usually describe Addyi’s effect as “modest.” In company studies, women taking flibanserin reported a slight increase in sexually satisfying events each month. Their answers to separate questionnaires indicated they experienced a slight increase in desire and a slight decrease in stress.
While FDA scientists describe these effects as “small,” they were significant enough to meet FDA effectiveness standards.
What Are the Side Effects?
About 10 percent of patients in Sprout’s studies experienced the most common problems: dizziness, fatigue and nausea. The drug will also bear a boxed warning that women should not drink or take certain types of other medications, including antifungal drugs, because of an interaction that can cause low blood pressure and other drugmakers.
“It’s just a mishmash of politics and science and sex and money,” Tiefer said.
The lobbying group, dubbed Even the Score, began publicizing the lack of drugs for female sexual dysfunction as a women’s rights issue last year.
“Women deserve equal treat-
How Much Will It Cost?
Sprout says women who have health insurance will pay between US$30 and US$75 for a month’s supply of Addyi, depending on their coverage terms.
Why Did the FDA Approve Addyi
This Time Around?
When FDA regulators first rejected Addyi in 2010 they noted that the drug failed to achieve a key study goal — increasing desire based on patients’ daily journal entries. Because of that lack of effectiveness, they said, the drug’s negative side effects outweighed its benefits.
Since then, Sprout conducted another study of sexual desire using a different method that achieved statistical significance. The company also conducted several safety studies to more clearly define the drug’s risks, which are outlined in its warning label.
While the FDA is required to make all decisions based on science, critics say that the concerted lobbying effort by Sprout-funded supporters also played a role in Addyi’s approval.
When Will the Drug Be
Sprout plans to launch the drug in mid-October. ment when it comes to sex,” the group states in an online petition to the FDA, which attracted more than 60,000 supporters. Women’s groups, including the National Organization for Women, signed on to the effort, though it was funded by Sprout and other companies working on female sex drugs.
In this June 22 photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, North Carolina headquarters. The U.S. Food and Drug Administration, Tuesday, Aug. 18, approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.