‘Female Viagra’ Addyi Deemed a Failure as Drug Company Cuts its Losses

addyiCast your mind back to August 2015 when the Food and Drug Administration (FDA) in America approved a drug called ‘Addyi’, excitement reached fever pitch about the new pill to boost female sexual libido, a pill that many were labelling as the ‘female Viagra’…though numerous health experts have criticised this description.

The History of Addyi

Boehringer Ingelheim were responsible for the development of ‘Flibanserin’, before it became known by its trade name of Addyi. However, this process somewhat came to an abrupt halt in October 2010 after a negative assessment of the drug by the FDA.

Sprout Pharmaceuticals then acquired the rights to Flibanserin and they eventually managed to get the green light for FDA approval on 18th August 2015 for the treatment of premenopausal women with low sexual desire that causes personal distress or relationship difficulties, with the proviso that women were warned of the possible side effects that the treatment could bring about.

Addyi’s Side Effects and Cost

These side effects including a dangerous drop in blood pressure and fainting – especially when taken in conjunction with alcohol. Side effects weren’t the only problem with Addyi (Flibanserin), unlike the male erectile dysfunction medication Viagra which is taken only when required (about an hour before sex), Addyi has to be taken on a daily basis to be effective.

Moreover, although the cost-per-pill is roughly equivalent to Viagra, because Addyi has to be taken every day to be effective – and even as long as 4 to 8 weeks for women to see benefits – the fact is required daily means that the monthly cost of taking the treatment can spiral to around $780 (£594).

It is believed that Addyi affects chemicals in the brain, though it is still unclear exactly why it causes an increase in sexual desire, boosting levels of dopamine, a chemical associated with appetite, and lowers serotonin, which is linked to mood and feelings of happiness.

The libido-boosting treatment failed to drum up much interest from women in America however, shockingly only seeing 227 prescriptions for it within the first initial weeks on the market back in autumn 2015, from October 17th to November 6th.

In stark contrast, in 1998 when Viagra first hit the market, almost 600,000 prescriptions were filed for the ‘little blue pill’, as it was often referred to, and almost 20 years later it is still the go-to treatment for millions of men around the world suffering with erectile dysfunction.

Mistakes from Addyi’s Manufacturers

So, what went wrong with Addyi? Firstly, barely a day passed after gaining FDA approval when Sprout Pharmaceuticals sold the drug on to Valeant Pharmaceuticals for a whopping $1 billion. Although they were a prescription drug giant with increasing stock prices, many industry insiders claimed that Valeant had massively overpaid, whilst others were sceptical of Addyi and predicted a huge fail and subsequent withdrawal of the treatment in the coming years.

Soon after getting their hands on Addyi, Valeant faced negative publicity for price gouging and suspected links to a dubious mail order drug distribution company named Philidor. Fast forward a few months and Valeant’s stock price plummeted, it cut ties with its distributor, and the furore around Addyi had quickly run out of steam.

All the aforementioned, coupled together with Addyi’s unremarkable effectiveness for its supposed purpose, the high monthly costs to be on the treatment, concerns about serious side effects and the fact women couldn’t drink whilst on the treatment, meant that the drug was probably doomed from the start.

However, Sprout argued that Valeant had improperly marketed the treatment and last year put motions in place to sue Valeant. The main complained was the fact that sales of the pill seem to have totalled less than $10 million in 2016, nowhere close to the $1 billion initially targeted by July, 2017. Sprout’s investors had been entitled to some of the profits and were clearly unhappy with the poor showing from Addyi and Valeant’s handling of the drug.

Perhaps wanting to rid themselves of the poisoned chalice and also avoid forking out an even bigger amount via court fees and a possible loss in court, Valeant have amazingly handed the reigns of Addyi back over to Sprout’s investors, without any upfront fee. Instead, Sprout have agreed that Valeant will received a 6% share of future profits from the product (should there be any), and Valeant have even handed over £25 million loan to fund initial operating expenses.

Where the ‘female Viagra’ Addyi goes from here is anyone’s guess. It is safe to say the medication was handled and marketed abysmally from the offset and this, together with suspicions about efficacy and side effects, have led to an incredibly low interest from women and huge losses for Sprout and Valeant.

The future seems quite bleak for Addyi and it’s impossible to predict just how Sprout can turn the grim situation around. Also, many women can probably treat a low sex drive with simple things such as dietary and lifestyle changes, or attending sex therapy sessions, without ever needing to take a medication that never truly appealed to the masses.

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