The FDA has given regulatory approval to drug Addyi (otherwise known as flibanserin) – the first-ever drug designed to specifically boost women’s sex drives.
The committee voted 18-6 to recommend that the FDA approve flibanserin, a drug designed to boost the low sexual desire of otherwise healthy women.
In a move described as the biggest breakthrough for women’s sexual health since the Pill, Addyi has had ‘life-changing’ results for women who monitored their sexual desires during the trial phase.
Addyi, nicknamed the “pink Viagra” by stateside media, will work by targeting the brain’s sexual-excitement neurotransmitters.
Before you get too excited, the agency has already rejected the drug twice, saying the potential side effects of fainting, nausea, dizziness, sleepiness and low-blood pressure outweighed its benefits. When it came to testing each phase of the drug, 13% of participants dropped out of the clinical trial due to unwavering side effects.
In the final proposal to the FDA, Sprout Pharmaceuticals who developed the drug presented the results of a series of double-blind clinical trials that showed the drug worked better than placebo to boost women’s sexual desire, increased the number of sexually satisfying events and lowered women’s distress at the loss of their libido.
The drug’s approval has now been teamed with a list of conditions including warning labels, an education programme, prescriber training and certification.
