Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.
The Food and Drug Administration granted approval of the drug, Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 days.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings," said Dr. Tiffany Farchione, FDA's director of psychiatric drugs, in a statement.
Postpartum depression affects an estimated 400,000 people a year, and while it often ends on its own within a couple weeks, it can continue for months or even years. Standard treatment includes counseling or antidepressants, which can take weeks to work and don’t help everyone.
The new pill is from Sage Therapeutics, which has a similar infused drug that’s given intravenously over three days in a medical facility. The FDA approved that drug in 2019, though it isn’t widely used because of its $34,000 price tag and the logistics of administering it.
The FDA's pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients.
Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to enroll in a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with her children.
“I planned my pregnancies, I knew I wanted those kids but I didn’t want to interact with them,” said McMahon, who lives in New York City. She says her mood and outlook started improving within days of taking the first pills.
“It was a quick transition for me just waking up and starting to feel like myself again,” she said.
Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong” and the drug likely will be prescribed for women who haven’t responded to antidepressants. She wasn't involved in testing the drug.
Still, she said, the FDA should have required Sage to submit more follow-up data on how women fared after additional months.
“The problem is we don’t know what happens after 45 days,” said Yonkers, a psychiatrist who specializes in postpartum depression. “It could be that people are well or it could be that they relapse.”
Sage did not immediately announce how it would price the pill, and Yonkers said that'll be a key factor in how widely its prescribed.
Side effects with the new drug are milder than the IV version, and include drowsiness and dizziness. The drug was co-developed with fellow Massachusetts pharmaceutical company Biogen.
Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.
Sage's drugs are part of an emerging class of medications dubbed neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions.
© Copyright 2023 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.
17 Comments
virusrex
The true value of the drug remains to be seen once it it used more commonly, but if the preliminary reports that justified its approval are confirmed this can become a very useful tool for this very serious problems.
If the drug is safe and effective enough it still remains the problem of price, but taking into account the problem affects so many people it may justify making it accessible so profits can be made by the volume of people treated even if individual treatment is priced close to the cost.
cuddly
Always good to see the FDA backing these drugs.
The Food and Drug Administration granted approval of the drug, Zurzuvae,
virusrex
That is still not what "backing" means, the drug was developed and tested without any kind of help from the FDA, which is understandable since it has no role supporting any drug, just approving them.
餓死鬼
Yikes. I can imagine it’s not widely used. Is that what a three-day stay in a hospital with an IV drip costs in the U.S.?
Wick's pencil
Why doesn't the article mention that suicidal thoughts and loss of consciousness are among the possible side effects, and the lack of clinical trials?
Strange, but considering what happened during the past three years, not surprising.
nosuke
Please stop recommeding and andvertisng drugs for the pharam. Only in the USA this happens on national TV.
Not good abut good to be aware that there are potential drugs for your problem but you got to remeber that Pharama not interested in Healing/Cure of your problem but to keep you on drugs they sell thats why they are a multibillion dolllar business and the da man name V rex knows this
cuddly
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings," said Dr. Tiffany Farchione, FDA's director of psychiatric drugs, in a statement.
Strong backing by the FDA, as the US makes more important advances in the pharmaceutical field.
virusrex
That would be because there are clinical trials, and they demonstrate a benefit for the patients that are treated with the drug, this is not something to be sold over the counter, so as with every other drug that is used under supervision of a medical professional risks and benefits are part of the things discussed with this professional in order to be used.
The article is describing something that appears to be beneficial for some people, what is your suggestion? to hide pertinent information and let people suffer from a condition that can end up in tragedies just so nobody can profit from helping them?
Once you lower yourself to make personal attacks instead of arguments you are recognizing openly that you have no arguments to use.
A similar drug is currently available but deeply inaccessible for most people, that would be a terribly show of "backing" which again is understandable since the role of the FDA is just to approve or not the drug.
gcFd1
The FDA's pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill.
Agreed that this global health authority, the FDA, has backed several new helpful drugs lately.
Good on them.
virusrex
Still not a global health authority according to your own standards (that would require the FDA to have global legal powers) nor approving something means backing it up.
The easiest way to see how this is the case is seeing how you could not even argue against the arguments that disprove both claims, you just repeated them as if they were not already refuted.
Strangerland
Ohh, they don't say they are global. So they're hiding their authority in other countries? And these other countries are hiding it with them? So they're conspiring with the other counties to hide their global authority status in a ... conspiracy? Is that your theory?
It all sounds very frightening. Have you considered telling someone, or maybe the aluminum foil head fashioning protection?
cuddly
There is no doubt in the medical world that the FDA is a global health authority. The impact of these types of backing are felt around the world.
virusrex
Yet you have been completely unable to find even one reference that says so, just your personal claim, which completely contradicts also the claim you make that the FDA would need to have global legal powers to be an authority. Which is it then?
The impact comes from the development of the medical interventions, or by the actual support by international organizations or global public health authorities (the WHO) to facilitate the access to those drugs, not just by approving their use on one country.
cuddly
Your personal opinion/trolling does nothing to disprove the facts.
Calling the WHO a global health authority when it has zero legal authority is laughable.
Do you even think before you post your personal opinions, especially the ones way out there?
virusrex
You tend to attack other people and call them trolls every time you end up mistaken, that do not make the argument a personal opinion.
You have not provided any reference that called the FDA a global health authority, and you still contradict yourself by saying it would need to have global legal powers (which obviously it does not have). Those would be the facts.
The WHO is a well recognized global health authority. including by the US goverment
https://www.kff.org/coronavirus-covid-19/fact-sheet/the-u-s-government-and-the-world-health-organization/
What evidence do you have to contradict what even the US government says about the WHO?
cuddly
When someone is being a troll, it is fine to clal them out as such, or do you disagree?
Provide a quote where I wrote the FDA would need to have global legal powers.
You can't, because you just made that up.
Even if your personal opinion were true, this does not prove the FDA is not a global health authority.
Contradict what? The US doesn't say the WHO had any legal authority.
What evidence do you have that the US or any other country says the WHO has legal authority?
Roy Sophveason
Yet you insist on characterizing the FDA as a "global health authority" despite it having no legal authority outside of the US.