The new pink pill is considered “Viagra for women” – but the name is a bit misleading. Of Viagra-active ingredient Sildenafil helps if the man has desire, but the body is not very nice; the medium enhances the erection. The now approved in the US Flibanserin acts on neurotransmitters in the brain: So it’s supposed to promote sexual desire.
The US food and drug administration (FDA) has approved Flibanserin now. Twice – 2010 and 2013 – had been rejected, and now, finally, the manufacturer, Sprout Pharmaceuticals has had success. “Addyi” is intended to mean the product when it comes out probably in October on the market.
For whom the agent is supposed to be interesting?
The FDA has approved the use of Flibanserin for premenopausal women who suffer from a lack of sexual Desire disorder (“HSDD”, which is short for Hypoactive Sexual Desire Disorder). It must be excluded that the listlessness is due to life circumstances, such as pregnancy and lactation, diseases, medication intake, or by an unhappy partnership, declare.
How many women are affected?
According to surveys, in the United States, about 8 to 14 percent of women between 20 and 49 years of age. However, the diagnosis is controversial. Many experts say that a low sex drive is not a disease.
In the prestigious “British Medical Journal” described by Ray Moynihan in the year 2003, the sexual disorder of the woman as the latest example of the Invent a new disease by corporations. In 2010, he summed up how the industry has promoted surveys, the Problem as far-reaching, and how she helped to develop the diagnostics, with the “women are convinced that their sexual problems are in need of a medical name and require treatment”.
The FDA sees HSDD as a diagnosis, which would have required urgent treatment options develop.
What are the results of the pivotal studies?
The FDA’s decision is based on several studies in which the subjects either Flibanserin or a Placebo. It was queried how often the women experienced satisfying Sex (via journal entry) and how often they felt sexual desire. In addition, it was recognized how strong you suffered from listlessness.
In the first two submitted studies, Flibanserin revenue, only a difference in terms of satisfying sexual activity was revealed between the Placebo group and those women. In the third, there were also the other two points of improvement compared to the Placebo.
On average, the women reported to the study start-up of 2.7 satisfying sexual experiences per month. In the Placebo group, the number rose in the last study of 1.5 – in the Flibanserin group 2.5.
Overall, the effectiveness of Flibanserin is rather low – what are the two times of the admission Decline suggests.
In the approval studies, the resources helped approximately 40 to 60 percent of the treated women. The package insert should contain according to the FDA, the note, the drug discontinued, if to notice after twelve weeks, no effect.
How does Flibanserin?
Flibanserin acts on the neurotransmitters Serotonin and dopamine. The drug was originally tested by the pharmaceutical company Boehringer Ingelheim as an antidepressant, later, the US company, Sprout Pharmaceuticals, took over him. The agent should be taken for the now-approved therapy daily.
What side effects are known?
Dizziness, Nausea, drowsiness, exhaustion: About ten to eleven percent of the women complained of, respectively, the Flibanserin revenue. In the Placebo group, only between two and five per cent have to fight with these problems. Also insomnia, a dry mouth and feelings of anxiety occurred with the drug more frequently.
The active ingredient in combination with certain other medications and alcohol dangerous side effects. In the United States Addyi is provided “” with a warning. Blood pressure waste to fainting, threaten, women should take other medications or drink alcohol.
In the report of the FDA for approval is: “The safety of Flibanserin is improved if it is taken at bedtime by patients who know that the active ingredient dizziness, low blood can cause pressure and fainting.” By taking on the day is not advised. Doctors should be trained, before they prescribe the drug.
To put it differently: There are serious side effects.
Is it a must?
First of all, one has to ask the question of when a lower sex drive, a treatment. The Chairman of the German society for sexual medicine, Uwe Hartmann says: “From my experience, most women do not suffer from their unwillingness. They come to me because they have worries that their relationship is in the doldrums in the bed breaks.”
So far, those Affected will be offered psychotherapy. It must be, indeed, that in a relationship one of two medications, just because they both feel differently, and often in the mood for?
Then you have to ask yourself: If handle, really, with this drug, in addition to the modest efficacy of serious side-effects can bring?
In summary: The FDA has approved Flibanserin, brand name Addyi, for the treatment of sexual listlessness of women. The agent has a low efficacy and may, in particular, have in combination with alcohol serious side effects, which is why this step is criticized. The extent to which a lower sex drive ever needs to be treated, is also controversial.