Female libido pill maker Sprout bought by Valeant for $1 billion

Sprout Pharmaceuticals – the company that on Wednesday won approval to sell its female libido drug “Addyi” in the US – wants to start working with worldwide drug regulators to market the product globally.

“My marriage has suffered greatly, so much so that the conversation of divorce is on the table, stemming from my low sexual desire“, one woman said before the FDA panel.

Rebecca Zucconi, a gynaecologist and assistant professor at Quinnipiac University, said Addyi, while not a highly impressive drug, provides an alternative to the counselling and psychotherapy that have been a mainstay of treatment for women with low sexual desire. Fainting, dizziness and sleepiness are among its rare but serious side effects.

Yesterday the Food and Drug Administration in the US approved flibanserin, a treatment for some premenopausal women who have lost their desire for sex. It was initially developed as an antidepressant, then abandoned by the German drug company Boehringer Ingelheim for lack of effectiveness. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. The distribution of Addyi is also strictly limited to specially certified physicians and pharmacists.

“This is a transformational moment, hopefully across all of women’s health care, certainly in women’s sexual health”, Cindy Whitehead, chief executive officer of Sprout, said. These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body.

Sprout’s bid to get flibanserin approved on its third try has stirred controversy and debate among doctors, feminist groups, consumer advocates and researchers specializing in female sexuality.

FDA warns that the drug can lead to loss of consciousness and cause the blood pressure to drop.

Among Addyi’s supporters was Amanda Parrish, a 52-year-old resident of Brentwood, Tenn., who tested the drug in an early clinical trial. They increase blood flow and are designed to be taken shortly before sex.

“If it were to be available in New Zealand I have no doubt some women would seek to use it and see if it helps them”. Addyi doesn’t treat a physical problem for women – instead it targets the chemicals in their brain and it improves, in at least 37% of the women who take it, their sense of desire for their romantic partner. Some women experienced as many as six to eight more satisfying sexual events each month, Ms Whitehead said. In addition, use of alcohol is contraindicated while taking flibanserin.

“I think this is going to change the conversation that’s taking place in medical offices across the country”, Streicher said. The company will focus its 200 sales representatives on promoting the drug to medical specialists.