An injection that would enhance sex drive among women has been approved by the United States Food and Drug Administration (FDA) on Friday.
This is however not the first such medication that has been approved by the FDA. Earlier in 2015, the US regulator had given approval for a similar pill called Addyi from Sprout Pharmaceuticals. That pill however got embroiled in controversy where in there was raging debate whether low sex drive in women could be considered to be a health condition or a mental health related issue.
The trade name of Vyleesi would be given to the newly approved drug – bremelanotide. This new drug would be available in the form of an injection aimed at increasing the libido in women users. It has been developed by Palatin Technologies, which granted exclusive licensing rights to Amag Pharmaceuticals.
The functioning of the newly approved drug does not work like Viagra – which caused a rush of flow of blood in men towards their genitals. According to a statement issued by Palatin, the functioning of the Vyleesi involves the drug activating pathways in the brain which are linked to the sexual responses mainly in the body of women. Users would be able to apply or inject the drug themselves using an auto-injector and has been prescribed to be taken at least 45 minutes prior to having sex.
It has been reported that if the new drug is able to meet certain sales milestones, up to $300 million from its deal with Amag would be received by Palatin. And since the FDA has approved Vyleesi, more than $600 million would now be collected by Palatin.
The drug has been used on more than 2,500 people in more than 30 clinical trials, Palatin says. For those women who are at their pre-menopausal stage and those with hypoactive sexual desire disorder, this drug has shown significant effectiveness as a means of treatment in phase 3 studies, the company said. The full trial results have not been made available. This condition in women is one where they tend to lose interest in sex. According to estimates by Experts, such conditions exist in one in ten women.
“We’re obviously thrilled about being able to bring another option to patients,” Dr. Julie Krop, the chief medical officer of AMAG, which is based in Waltham, Mass told the new York Times in an interview about the approval. “These women have suffered significantly, pretty much in silence, for a stigmatized condition, and many of them have not known that it’s a treatable medical condition.”
There was however no information given by the company about the probable price of Vyleesi would but said hat that more details about the product would be disclosed at the time of its launch for sale later this year.
Almost six million American premenopausal women suffer from low sexual desire, estimate the company which is also into the business of producing other products for women’s health.
(Adapted from CNBC.com)