The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).
However, the agency still advises patients to wait two hours after the last drink before taking Addyi. In addition to the alcohol contraindication removal, the FDA also removed the requirement for health care practitioners and pharmacies to be certified to prescribe or dispense the medication through the Risk Evaluation and Mitigation Strategy program.
"This is an important day for Addyi and for the treatment of the most common form of female sexual dysfunction, HSDD," James A. Simon, MD, clinical professor at George Washington University, said in a press release. "With the data and science on its side, it's not surprising to see the FDA remove an unnecessary alcohol contraindication and certification requirement. HSDD is a condition that can negatively impact relationships, self-esteem and quality of life. Improving access to treatment with Addyi for the millions of women suffering represents a major milestone in women's health."
The CEO of Sprout Pharmaceuticals, Cindy Eckert, said it is the second most important day for Addyi, after the day it came out, because it will now be easier for women to obtain the medication. Women can now go to any doctor or visit Addyi.com to get a prescription and have the option to try the medicine for free for two months.
