FDA releases Industry Guidance for Low Sexual Interest, Desire and/or Arousal in Women
In late October 2016 the US FDA released draft guidance for Industry on Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment.
This document states ” Sexual dysfunction can adversely affect various aspects of life for a woman, including her relationship with her partner. There is a medical need for development of drugs with favourable benefit-risk profile to treat women with sexual dysfunction.”
This is a watershed publication with the world’s most stringent regulator acknowledging female sexual dysfunction is real and treatments are required.
Australia is unique in this area of female health, because unlike the rest of the world, Australian women and doctors have access to our clinically proven product that addresses this important area of female sexual health.
Because the FDA have clearly defined the regulatory pathway forward Lawley plans to undertake large scale clinical efficacy and safety studies to ultimately gain FDA and European regulatory approval.