A delightful announcement was made by Sprout Pharmaceuticals that the Food and Drug Administration (FDA) has made a decision about the current warnings & restrictions regarding the use of alcohol by women who intake Addyi to treat the acquired HSDD (Hypoactive sexual desire disorder) are more than restrictive and tend to exaggerate the risk of alcohol interaction.
This pronouncement was delivered by 3 fresh Addyi alcohol interaction studies which gave a demonstration that no orthostatic hypotension required medical attention. To the International Society for the study of women’s sexual health and other renowned medical societies concerned with women’s sexual health, this database was presented and submission was made to the FDA eight months back.
On the 11th April, An order by FDA to change the label of Addyi was received by the Sprout in order to reduce the restriction on alcohol. Once the label change will be implemented, there will be an assurance that the healthcare providers and the same patients are confident enough to make informed & accurate decisions with the findings of this study.
Sprout Pharmaceuticals have preferred to remain in contact with the FDA and continue the discussions to make sure that all the elements of labeling are aligned with the well identified scientific data by means of a standard appeal process.
Chief Executive Officer of Sprout Pharmaceuticals, Cindy Eckert stated: “The FDA labeling revisions, and additional changes that Sprout is continuing to discuss with the FDA, should finally allow women suffering from HSDD much greater access to the only approved treatment, Addyi. FDA, like us, recognizes that women want access to treatment for this condition and their label order reflecting that women taking Addyi may safely consume alcohol is a positive step. We are encouraged to continue to work with them so that all of Addyi’s labeling elements are consistent with the safety and tolerability findings.”