“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering it for treatment,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said in a statement. As specified, this substance is intended for treatment and not for stimulate pleasure. Statistically, 10% of U.S. women population in the U.S. are affected by sexual desire disorders. Supporters of the new drug argued it gives women more options and enable them to take control over their waning sexual lives. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction,” said Janet Woodcock.
Pharmacies must be certified with the REMS program by enrolling and completing training before giving the new drug to patients. A Boxed Warning to highlight the risks will be required to be printed on the drug’s embalage. Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.