Why Addyi, billed as ‘female Viagra’, is not really a wonder drug

Addyi medically known as flibanserin, comes with its fair share of controversies

Written by Shruti Dhapola | Published:August 20, 2015 4:42 pm
Addyi, FDA approves female viagra, flibanserin, FDA approval flibanserin drug, Female sex pill, Female Viagra, flibanserin effective, flibanserin studies, Female Viagra effectiveness, flibanserin approval, Viagra, Society, Health, Female sexuality In this photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company’s Raleigh, N.C., headquarters. (Source: AP)

Addyi, Sprout Pharmaceutical’s drug that could boost low sex-drive in women, was granted an approval by the US FDA earlier this week, a decision that didn’t come easily. The drug aims to treat a condition called Hypoactive Sexual Desire Disorder (HSDD), which affects pre-menopausal women, and results in an unexplained loss of sexual drive.

The prescription drug being billed as the ‘Female Viagra’ had already been rejected twice by the FDA but now that approval has been granted it could hit the store shelves in the US by October.

But Addyi medically known as flibanserin, comes with its fair share of controversies.

Approval with boxed warning

The first approval came in June 2015, when the FDA advisory panel voted in favour of the drug flibanserin and sent forth its recommendation to the FDA. According to this news report from NationalPost.com, the margin was 18-6 which means even the advisory board did not unanimously approve the drug.

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“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr Janet Woodcock, Director of the FDA’s drug centre.

From its tone, the FDA does not see flibanserin as a quick pill solution that should be prescribed to all patients. A fact made clear, given that this prescription-only drug will come with a boxed warning. The warning will say that the drug could lead to dangerously low blood pressure and fainting, a risk that will be higher if Addyi is taken with alcohol.

Additionally the Associated Press reports that the drug can cause problems when taken with other “commonly prescribed medications, including antifungals used to treat yeast infections.”

Addyi, FDA approves female viagra, flibanserin, FDA approval flibanserin drug, Female sex pill, Female Viagra, flibanserin effective, flibanserin studies, Female Viagra effectiveness, flibanserin approval, Viagra, Society, Health, Female sexuality Sprout Pharmaceuticals CEO Cindy Whitehead (not seen in pic) holds a bottle for the female sex-drive drug Addyi at her Raleigh, N.C., office. (Source: Associated Press)

How does Addyi work?

While Viagra works on increasing blood flow to male genitalia, flibanserin acts on brain chemicals that affect mood and appetite. According to a Reuters report, “flibanserin is in the same class of other drugs known as selective serotonin reuptake inhibitors, or SSRI’s, that include antidepressants such as Prozac.”

A report on Throb Gizmodo, which is linked to various studies on the drug, explains in detail that flibanserin binds with serotonin receptors in the brains. While it reduces activities in 5-HT1a type receptors, it does the opposite with 5-HT2a receptors.

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The drug appears to have “the strongest quieting effect on the cerebral cortex, where all that ‘self-judging’ activity is taking place,” adds the report, thus giving it the link to boosting sexual desires.

Another study that also examines how flibanserin works on these two class of serotonin receptors concludes that where treating sexual disorders goes, it’s still a may and not a resounding yes.

The conclusion for the study reads, “Flibanserin is a 5-HT1A agonist and a 5-HT2A antagonist, with regionally selective actions on monoamines. Chronic treatment reduces 5-HT activity and enhances DA (dopamine) and NE (norepinephrine) activity in PFC (pre-frontal coxtex), which may act to increase the efficiency of information processing in critical pyramidal neurons linked to the symptoms of HSDD.” Full study available here. Some more studies on how flibanserin acted an anti-depressant on rats can be read here.

Based on studies, Addyi’s claim as a wonder drug stands on shaky grounds.

Addyi, FDA approves female viagra, flibanserin, FDA approval flibanserin drug, Female sex pill, Female Viagra, flibanserin effective, flibanserin studies, Female Viagra effectiveness, flibanserin approval, Viagra, Society, Health, Female sexuality The drug, flibanserin, under the trade name Addyi, nicknamed “female Viagra” is shown in this undated Sprout Pharmaceuticals handout photo released. (Source: Reuters)

Addyi an equivalent to the male Viagra?

While the term female ‘Viagra ’might make for great headlines, with Addyi efficiency does not stand at 100 per cent or even at 50 per cent.

For instance, Sprout claimed that, “46 to 60 percent of the women in the trials had benefited from the flibanserin treatment.” But FDA didn’t agree with this assessment and put the number down to 10 per cent. Moreover, the FDA adds that if patients don’t see any improvement after eights weeks of using Addyi, they should stop taking it.

Nor is this a pill, that women can just pop each night before going out to boost their sex drive as some might think. “This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” Leonore Tiefer, a psychologist and sex therapist opposed to the drug, told the Associated Press.

It would appear that Addyi’s use and approval comes with a fair amount of caveats.

Sprout and the Even the Score campaign

Addyi’s approval also comes in the background of a highly politicised campaign by those speaking in favour of the drug. After the FDA twice rejected the drug, the body was called sexist.

The issue of Addyi and its effectiveness has been carefully framed within the context of women’s rights.

According to AP, Even the Score’s – a lobby that began publicising the lack of drugs for female sexual dysfunction since 2014 – online petition had more than 60,000 supporters. Interestingly Sprout has not revealed how much funding they offered to the campaign.

How serious is HSSD?

The Associated Press report states that surveys estimate that 8 to 14 per cent of women aged 20 to 49 have the condition, or about 5.5 to 8.6 million US women. But when it comes to a ‘low’ sex drive or desire, the exact reasons for why women suffer from this are harder to pinpoint.

Relationship problems, body-issues, medications are all potential factors when looking at reasons for a low sex drive. And effective or not, flibanserin might not be the ideal solution.

Perhaps more harshly, some doctors have called HSSD a made-up disease. Dr Adriane Fugh-Berman of Georgetown University Medical Center is quoted by NBCNews as saying, “Hypoactive sexual desire disorder was actually invented by pharmaceutical companies…It was originally invented to sell the testosterone patch…”

Other doctors in defence of HSSD, say that the Addyi aka flibanserin will reduce the distress some women may feel when it comes to lack of desire for sex.

While FDA might have granted Addyi approval under stringent conditions for sale and prescription, its proven effectiveness has been minimal if one were to look at studies.Coupled with its side-effects, Addyi, the ‘female Viagra’ is far from being a near perfect solution.

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