Take two for female Viagra: FDA to vote on injectable drug designed to boost women’s libido – despite flop of ‘the little pink pill’
- The injectable drug targets brain receptors to ease inhibition in women diagnosed with hypoactive sexual desire disorder (HSDD)
- The first so-called ‘female Viagra’ was approved in 2015
- But it proved a commercial flop because women couldn’t drink while using it (that rule was changed in April)
- This new drug, an injectable, does not have lifestyle restrictions, but its effects on desire are minimal
US regulators will vote this Friday on whether to approve a second drug that boosts sexual desire in women with chronically low libido.
The first so-called ‘female Viagra’ (sold under the brand name Addyi, also known as ‘the little pink pill’) was approved in 2015, but it proved a commercial flop, largely due to the fact that women couldn’t drink alcohol while using it.
In April, the US Food and Drug Administration ruled that women could drink on Addyi, and investors are holding their breath to see if that move triggers and uptick in demand and sales.
In the meantime, there is momentum behind another drug, bremelanotide, which has proved effective in two trials with 1,200 women – and, crucially, comes with no lifestyle restrictions.
Like Addyi pills, the injectable drug targets brain receptors (though, different ones) to ease inhibition in women diagnosed with hypoactive sexual desire disorder (HSDD), who have low libido and high levels of distress when intimate.
This week, regulators will have to decide whether the drug is necessary – a debate which will inevitably bring up the decades-old question: is HSDD a real disorder?
Part of the issue with HSDD treatments is that the condition itself is highly subjective, relies on an initial self-diagnosis, followed by a process of elimination, with doctors trying everything before they conclude that a patient has HSDD (file image)
While Viagra and Cialis increase blood flow to a man’s penis, Addyi (the brand name for flibanserin) and bremelanotide target the brain with similar effects to an antidepressant.
Addyi boosts dopamine to gear up motivation and excitement, and dulls serotonin, the neurotransmitter which makes us self-conscious.
Bremelanotide targets melanocortin 4, which eases distress and boosts desire.
In trials, bremelanotide proved markedly effective at reducing distress in women with HSDD: by the end of the trial, most saw a one-point reduction in distress, measured on a scale of 1-4.
Desire was more marginal – going up an average of 0.6 points on a scale of 1.2-6.
The manufacturers say even a slight increase in desire is significant for women with HSDD.
Part of the issue with HSDD treatments is that the condition itself is highly subjective, relies on an initial self-diagnosis, followed by a process of elimination, with doctors trying everything before they conclude that a patient has HSDD.
That makes diagnoses few and far between, or contested, and it makes it hard for regulators to deliver a clear-cut verdict on how ‘effective’ or ‘necessary’ treatments might be.
The American Sexual Health Association, a 100-year-old nonprofit source of sexual health information, says HSDD affects a staggering one in 10 women – and ASHA CEO Lynn Barclay told DailyMail.com visits to the HSDD page on their website have been rocketing in recent years and months.
However, many health professionals question whether HSDD is real.
The FDA’s verdict could be a key new step to settle – or stir- the debate.