“Breakthrough” Tx for Postpartum Depression: Game Changer or Misguided Magic Bullet?

[Pattypans]

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/

[Pattypans]

Interestingly, in this article the author also mentions the anti-depressant esketamine nasal spray recently approved by the FDA. (There are articles about both Zupresso and that nasal spray here on HH.) As she says in her article about the nasal spray, "Time will tell, but as I always say, we (the American public) are the real clinical trial. We pay the ultimate price for the lowering of FDA standards for drug approvals.” https://www.madinamerica.com/2019/02...or-depression/

[Islander]

This article highlights much of what is broken in our drug approval process. That so many genuine concerns are dismissed by the committee and overlooked by the press is alarming, to say the least — and once again demonstrates, if proof is needed, that it's all about the money.