Viagra-like drug approved in US to help women with libido

The FDA had twice rejected the drug, which is made by Sprout Pharmaceuticals.

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. “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies”.

While the FDA has approved numerous treatments for sexual dysfunction in men, the agency has been accused of gender bias for failing to approve any such medications for females.

At an FDA meeting in June, FDA advisers backed the drug with 18 votes for and six against. These include a boxed warning that highlights the risks of low blood pressure and fainting in patients who drink alcohol while taking the drug, as well as a requirement that doctors complete a training course before being allowed to prescribe it. Women should also avoid taking Addyi with certain other drugs, including some medications used to treat yeast infections.

The pill can be prescribed or dispensed only by doctors and pharmacists who watch an online slide presentation and pass a test of their comprehension.

The sexual disorder, as described by the FDA, “is characterized by a deficiency or absence of sexual fantasies and desire for sexual activity which causes marked distress or interpersonal difficulty, and is not better accounted for by another psychiatric disorder or due exclusively to the direct physiological effects of a substance or to the direct physiological effects of another medical condition”. “It’s complex. It’s not the same as a man taking a pill”. “Before long, I was the one suggesting we skip dessert and go back home to bed”, she wrote in Time magazine this year. According to FDA documents, flibanserin’s mechanism of action is not known, though clinical testing of the drug showed that the drug affects receptors in the brain associated with mood. That makes a direct comparison hard.

It is not clear if insurance companies will pay for Addyi. Sprout will assist patients with co-payments, she said.

This drug, which is supposed to be taken daily, would ideally target a mix of neurotransmitters so as to give that desire a boost. Although the reported benefits of flibanserin are modest, Sprout says the drug is effective.

About 2 million women are now seeking treatment for the disorder and more are expected to come forward once Addyi is on the market, said Carl Spana, CEO of Palatin Technologies Inc., which is developing its own female sex-drive treatment.

Critics say the benefits do not outweigh the potential side effects. “That’s a risk, too”.

Experts also raised questions about the increased risk of breast cancer seen in one of two studies on lab animals. Many years of research, trials, rejection, and a switch in pharmaceutical companies led to the first-ever drug to treat women with sexual dysfunction.

“It doesn’t treat all sexual dysfunction, it won’t help all women with sexual problems, but it will have a role in the therapy”.

Procter & Gamble failed to win approval for a testosterone skin patch for women about a decade ago. An FDA advisory panel in June recommended the agency reverse course and approve the drug.

Originally the drug was produced by German company Boehringer Ingelheim.