The US Food and Drug Administration has finally cleared Sprout’s Addyi as the first treatment for low female libido, but with a black-box warning and a risk management programme to ensure patient safety. 

Specifically, Addyi (flibanserin) can be used to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women, giving this group of patients access to an approved medicine for the first time.

The decision comes amid controversy and concern over the drug’s modest efficacy as well as safety issues, which in the past prompted two knock-backs from the regulator. 

However, in June this year an FDA advisory committee said it was satisfied that Addyi’s benefit outweighed its risks, voting 18-6 in favour of its approval, as long as steps are put in place to protect patients from side effects.

Black-box warning

As such, its label carries a black-box warning on the risk of low blood pressure and fainting, which is magnified in the presence of alcohol, while a linked risk evaluation and mitigation strategy requires that only certified prescribers and pharmacists are allowed to dish out the drug.

The agency has also stipulated that healthcare professionals assess the likelihood of the patient “reliably abstaining from alcohol” before prescribing Addyi.

Addyi, which was originally discovered by German drugmaker Boehringer Ingelheim, is a serotonin 1A and 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known.