The first prescription drug to boost women's sexual impulses was approved by regulators on Tuesday, and a lobbying campaign won, which accused the Food and Drug administration of ignoring women's sexual needs, gender bias exists. The drug —
Addyi from Sprout Pharma
In fact, this is the first drug to approve the treatment of any kind of weakened or missing sexual desire.
Viagra and other drugs available to men are approved to help with erection, or to treat certain defects in hormone testosterone, rather than increase desire.
Advocates calling for approval of Addyi say a drug to improve women's sex life is long overdue, and many of them are members of the alliance called Score the Score, considering men have a lot of options.
"This is the biggest breakthrough in women's sexual health since birth control pills," said Sally Greenberg, executive director of the National Consumer Union . ".
But critics say the campaign behind Addyi is a mockery of the system that regulates drugs
The women's movement was chosen to F. D. A.
Approval of one of the most effective drugs can lead to side effects such as lower blood pressure, fainting, nausea, dizziness and drowsiness.
The doctor is announcing approval.
Senior F. Janet WoodcockD. A.
The official said the agency is "committed to supporting the development of safe and effective treatments for female sexual dysfunction. ”The F. D. A.
The decision on Tuesday was not surprising, as the external expert advisory committee recommended approval of the drug in a vote of 18 to 6 on June, although precautions need to be taken to limit the risk and ensure that the risk is not overused.
Addyi's label has boxed warnings-
The strongest one.
People who say they drink should not use the drug because it can increase the risk of severe depression and fainting.
It also cannot be used with certain other drugs and people with impaired liver function.
This pill can only be prescribed or administered by doctors and pharmacists who watch the online slide presentation and understand the test.
If women do not see the effect after eight weeks, it is recommended that they stop using the drug.
The big question now is how many people will use Addyi (pronounced ADD-ee)
Also known as flibanserin, is called "pink Viagra ".
According to a survey, about 10% of women suffer from decreased sexual desire. The F. D. A.
The drug is said to be approved for women whose loss of sexual desire leads to obvious pain or difficulty in interpersonal relationships, rather than disease, relationship issues or side effects of other drugs. Dr.
Lauren Stryker, associate professor of clinical obstetrics and gynecology at Northwestern University, said she felt her patients were very interested in drugs like Addyi.
The listing of the drug will encourage many women to talk to doctors about their sexual problems for the first time, she said.
"I think this will change the ongoing dialogue among medical institutions across the country," she said, adding that while Viagra was granted 1998 approval, it was acceptable for men to talk about erectile dysfunction.
Leonore Tiefer, a sex therapist at New York University School of Medicine and critic of the drug, predicts that limiting use will prevent Addyi from becoming popular.
"It will be more troublesome than its value," she said . ".
Cindy Whitehead, Sprout's chief executive, declined to predict sales of Addyi, who she said will start selling from October. 17.
In an effort to alleviate concerns that the drug would be overused, Spott said it would not advertise on radio or television for 18 months after the drug was approved. Ms.
Whitehead says the company's marketing focus will be on doctors, not consumers.
Sprout plans to hire 200 sales reps, enough to visit about 30,000 doctors, mainly obstetricians and gynecologists, as well as some psychiatrists and primary care doctors, she said.
The exact price of Addyi has not yet been decided, she said, but it is recommended that it be roughly equivalent to the erectile dysfunction pill per month.
These pills are usually taken when needed, while Addyi should be taken before going to bed every night.
This makes it more difficult to direct.
But the price of 10 Viagra tablets (which may be distributed every month) is about $400.
It is not clear whether the insurance company will pay for Addyi. Ms.
Whitehead says she expects a lot of people
About $30 to $75 a month.
Spout will help patients
Payment, she said.
Some doctors may use the drug outside of the use on the label, which the doctor allows. Dr.
Streicher said that although the drug was only approved for use in premenopausal women, she would also "absolutely" prescribe it for post-menopausal women. Dr.
Irving Goldstein
A medical doctor in San Diego, who has been a consultant to Sprout, said he would not necessarily refuse temporary drinkers to take the drug.
Some women may find that if their relationship is in danger because of a lack of desire, the risk of side effects is acceptable, he said.
"This is also a risk. ”Dr.
Goldstein said he also did not rule out the drug. label to men. Ms.
Whitehead says there is an interest in finding out if the drug is effective for men, but the priority for spplot is to get approval in post-menopausal women and in foreign markets.
Addyi is believed to work by changing the balance of certain brain neurotransfersin, such as dopamine and 5-amine.
The researchers divided the composition of women's normal sexual desire.
There are difficulties in bringing a drug that treats low desires to market.
About a decade ago, P & G failed to get approval for a female testosterone skin patch. The F. D. A.
Addyi was rejected twice in 2010 and 2013 on the grounds of marginal effectiveness and side effects.
For example, in a trial, there were an average of 4 women taking the drug.
4 times a month "satisfying sexual experience", compared to 3 times.
Women taking placebo and women taking placebo.
Before the study begins.
When measured with a daily diary, the drug does not increase desire than placebo, but when measured with a monthly questionnaire, it does increase desire.
After the first refusal, Bollinger Ingleheim gave up the drug. Ms.
Whitehead and her husband, Robert, were running a company that sold testosterone products for men.
The Whitehead family sold the company and set up a Sprout to buy flibanserin.
Headquartered in Raleigh, New YorkC.
She raised about $100 million, a private holding company. Whitehead said.
After being rejected for the second time, various women and health groups even scored points.
Sprout paid at least part of the cost for the alliance, which consists of the National Council of Women's organizations, the black women's health obligations organization and the Association of Reproductive Health Professionals.
Even after a favorable advisory committee vote, critics of the drug sent a letter to the FBI. D. A.
Urge it to reject Addyi.
The agency usually follows the advice of its committee, but does not have to do so.
A letter written by the doctorTiefer of N. Y. U.
Signed by about 100 others, it is "ridiculous" to say that young women who expect to take Addyi do not drink alcohol ".
Another PharmedOut project from Georgetown University Medical Center, which also has more than 100 signatures, says "unprecedented, baseless manufacturers --
Members of the advisory committee may be confused.
A third letter from sexual researchers in the Netherlands and Belgium says the drug is based on the wrong idea that it is not normal to lack spontaneous sexual desire, without stimulation.
Even scores are planned to continue doing business, hoping that the approval of Addyi will stimulate other companies to develop women's sexual health drugs.
"It's never been a treatment," she said . "
Greenberg of the National Consumer Union has received a contribution from Sprout, and even officially joined the alliance this month.
"It's too early for us to fold the tent up.