FDA Oks new female libido drug

June 24, 2019

The FDA has approved a new medication created to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.  

The medication, Vyleesi, was developed by Palatin Technologies and Amag Pharmaceuticals. Vyleesi will now compete with Sprout Pharmaceuticals’ Addyi, which got the green light in 2015, for a HSDD market that analysts believe could be worth $1 billion.  

Unlike Addyi, a once-daily pill, Vyleesi is designed to be injected in the patient’s abdomen or thigh about 45 minutes before intended sexual activity. Importantly, Vyleesi does not come with an alcohol restriction, which was added to Addyi’s label after studies linked the combo to dangerously low blood pressure. Although some patients suffered from nausea when using  Vyleesi, overall, studies showed that the drug had more tolerable side effects than Addyi. 

HSDD is marked by low sexual desire that triggers personal distress and relationship difficulties. The Society for Women’s Health Research estimates that one in 10 American women struggle with HSDD. 

Read the full Reuters report.