A new ‘female Viagra’ could be about to shake the market

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Palatin Technologies has announced successful results in the latest clinical trials of its new drug to stimulate sexual arousal in women. The company expects to seek approval from US regulators in the second half of 2017. If approved, bremelanotide will become the second ‘female Viagra’ on the market, joining another drug called Addyi. Following the announcement, Palatin’s shares rose 66%.

Analysts consider low female libido an untapped market worth $2bn, a niche that Addyi has failed to exploit. But as Palatin’s drug progresses through the clinical trials, the controversies surrounding ‘female Viagra’ remain unsettled.

Addyi’s failure

A year after its launch, the main beneficiaries from Addyi are its early investors. The day after Sprout Pharmaceuticals obtained Food and Drug Administration (FDA) approval for Addyi, pharma giant Valeant acquired the company for $1bn.

However, Addyi’s medical performance remains well below its market value. During the clinical trials, women that took the drug reported only one more satisfactory sexual event every two months than women taking a placebo.

The drug also has some strings attached. Women that decide to try it will have to take it daily and refrain from drinking alcohol; two important put-offs for many potential users.

Perhaps not surprisingly, the drug is not selling as well as expected.

‘Unmet medical need’ or a fictitious disease?

The FDA approved Addyi after its third review. They justified their approval despite its low effectiveness because they considered that women suffering from low libido have an “unmet medical need”.

Read on...

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This conclusion was not incidental. After the second rejection, in 2013, the company behind Addyi set up a public relations campaign that touted the previous rejections as ‘sexist‘. The campaign, endorsed by high-profile feminist advocates, centred around the idea that the dominant culture dismissed women’s sexual desire and pleasure as “not so important“.

But many women’s groups disagreed with this view. Some considered that the drug’s approval should follow an impartial process based solely on science. Others argued that behind the labelling of low female libido as a medical condition lies a marketing strategy. According to Cindy Pearson, from the National Women’s Health Network:

The condition called female sexual dysfunction has been promoted by pharmaceutical companies to justify prescribing drugs to healthy women. It’s not a real condition with a scientifically valid diagnosis. But female sexual dysfunction has been defined as a condition affecting 43 percent of women. That’s 68 million potential customers in the U.S. alone for the first drugmaker to get its “female Viagra” past regulators.

The new drug

The new ‘female Viagra’ has shown some improvements in effectiveness and could be more user-friendly. Similar to male Viagra, women will only have to take it before engaging in sexual activity. And so far, it seems that its use will be compatible with drinking alcohol.

The major drawback is that it won’t be manufactured as a pill. Instead, users will have to use an auto-injector to deliver the drug under the skin. And regardless of its pros and cons, the drug may remain controversial until more agreement develops around the need for such products.

Featured image via Flickr/Trantro

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