Vyleesi: FDA approves “viagra for women”

by NCN Health And Science Team Posted on June 22nd, 2019

The U.S. drug regulator on Friday approved Vyleesi, a Palatin Technologies and Amag Pharmaceuticals’ drug to restore sexual desire in premenopausal women, the latest attempt to come up with a therapy that some have dubbed as “female Viagra”.

The therapy, Vyleesi, will compete in a market which has seen previous attempts fail. Analysts have said that a drug that safely and effectively treats loss of sexual desire in women could eventually reach annual sales of about $1 billion.

Palatin’s shares jumped 44% to $1.93, while Amag shares rose 11.5% after market.

Vyleesi, chemically known as bremelanotide, activates pathways in the brain involved in sexual desire, helping premenopausal women with hypoactive sexual desire disorder (HSDD).

The drug will compete with Sprout Pharmaceuticals’ Addyi, a once-daily pill that was approved for HSDD in 2015 with a warning restricting alcohol use when on the medication. It will be available from September through select pharmacies.

Addyi was approved under intense pressure from advocacy groups despite a review by scientists at the Food and Drug Administration (FDA) that deemed it minimally effective and possibly unsafe.

Vyleesi, which does not restrict alcohol use, is seen as having several advantages over Addyi, including tolerable side effects, rapid-acting nature and not having to take it every day, according to analysts.

Side effects reported during clinical trials included mild to moderate nausea lasting no more than two hours and mostly occurred over the first three doses, Amag said. About 40% of patients in clinical trials experienced nausea.

The drug is administered as a shot into the abdomen or thigh using an auto-injector at least 45 minutes before anticipated sexual activity, with the FDA recommending patients not to take more than one dose within 24 hours or more than eight doses per month.

The drug was developed by Palatin and Amag holds exclusive North America sales rights. Palatin will get $60 million from Amag for the approval plus additional payments for certain sales milestones and royalties.

HSDD affects about 6 million women in the U.S., but few seek or receive treatment.

SVB Leerink analyst Ami Fadia said there will be a need for more direct-to-consumer advertising through social media, which could help in building awareness about HSDD.

“These women are just suffering in silence and so the market doesn’t really exist today,” Amag CEO William Heiden said.

Ladenburg Thalmann analyst Michael Higgins forecast Vyleesi sales could reach $732 million by 2030.

Company officials declined to say how much Vyleesi would cost and said they would provide more details when the product goes on sale later this year. They said they expected insurance to cover Vyleesi on a scale similar to Addyi and to male erectile dysfunction drugs — coverage of those drugs by commercial health care plans is mixed.

The company, which manufactures other products for women’s health, estimates that nearly six million American premenopausal women suffer from low sexual desire, a condition that largely goes untreated. The company said that market could translate into about $35 million a year for every one percent of affected patients who use their product. The drug was developed by Palatin Technologies, which licensed it to AMAG to sell in North America in 2017.

Vyleesi, also known as bremelanotide, has some advantages over Addyi. It is to be used only before sex, and can be taken with alcohol. But the drug also has drawbacks — it does involve needle injections, and in clinical trials, 40 percent experienced nausea after taking it. In all, 18 percent of women dropped out of the trial, including eight percent who stopped participating because of nausea.

In addition, about one percent of the patients who took Vyleesi in the studies reported darkening in their gums and parts of their skin, which did not go away in about half of the patients after they stopped treatment. People with high blood pressure or who have cardiovascular disease — or those at high risk for cardiovascular disease — should not take the drug, the F.D.A. said.

The drug was shown to improve women’s self-reported feelings of desire and lowered their distress around having sex, but it did not increase the number of “sexually satisfying events” they had in a statistically significant way.

Dr. Krop, of AMAG, said the F.D.A. no longer requires companies that test drugs for low female libido to count the amount of sex women have as a primary evaluation measure. That’s because, she said, women with low sex drive continue to have sex with their partners, they just don’t enjoy it. “They’re oftentimes having mercy or duty sex because they want to maintain their relationship,” she said. “The problem is, they’re distressed about having that sex that they are having.”

Some drug-industry critics questioned whether Vyleesi was the latest example of a company promoting a pharmaceutical solution for something that is, in reality, far more complex.

The low-sex drive disorder has long been promoted by companies that were seeking to develop treatments for women. AMAG operates a website, unblush.com, which seeks to raise awareness about the condition; the maker of Addyi sponsors a similar site.

“I think it’s worth noting what’s an acceptable level of libido is socially influenced,” said Dr. Adriane Fugh-Berman, a professor in the department of pharmacology and physiology at Georgetown University Medical Center who studies pharmaceutical marketing. “Making women care less about the bad sex that they’re having is a dubious goal.”

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