The author of this article is apparently the only Consumer Representative on an FDA Advisory Committee which debated whether or not to approve Zulpresso (brexanolone), and the only one who voted not to approve it. As a member of the committee, the author has a unique vantage point from which to comment on this part of the approval process.
Kim Witczak
March 28, 2019
Last week the Food and Drug Administration approved a first-of-its-kind drug specifically indicated for postpartum depression. The drug developed by Sage Therapeutics and marketed as Zulpresso (aka brexanolone) is administered as a continuous 60-hour IV drip, is fast acting, and its antidepressant effects can last for a month. Will it be a game changer for new mothers or just another marketing travesty?
Read more: https://www.madinamerica.com/2019/03...-magic-bullet/