The Food and Drug Administration on Tuesday approved brexanolone, the first drug specifically targeted to treat postpartum depression — the most common complication of childbirth. Yet it’s a condition that often goes untreated because new mothers fear being stigmatized if they report symptoms.
Brexanolone is the first drug developed by and approved from Sage Therapeutics. The Cambridge, Mass.-based biotech company will market the new medicine under the brand name Zulresso.
“This approval is important for postpartum depression patients and it’s important for our company. It’s rare in your career when you can introduce a new medicine that is different from what’s out there,” said Sage CEO Jeff Jonas.
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60 hour infusion?? That’s 2 1/2 days! Really? Are they hooked up the entire time? That’s depressing..
There is a gold rush on at the FDA. As long as industry insiders, former lobbyists and people whose only function is to ensure pharma profits, there will marketer generated hype like this. The most obvious suspicion would be the 36 thousand dollar price tag. The industry funded “studies” and RCTs can be easily gamed in our current alternate fact environment. We should be doubtful that the positions that were supposed to be scientifically evaluating these claims, are filled with the most qualified people.
It is really easy to find self selected subjects who would report and improvement, for a disorder that is hard to evaluate, treat or anticipate. Infusions that last for days, might provide a break or relief, that would only give the appearance that this stuff might work. It does not take much evidence, since the only factor here is increasing profits, not benefiting women with Postpartum disorder.
The cost of this medication alone would lead to under-reporting and deliberate misdiagnosis of the disorder. The only women who could afford this would already have nannies, and household help, giving them time to adjust.
Another Benzodiazapine to destroy more lives. This is a travesty that any doctor with a conscience would ever consider prescribing this drug to a new mother. We as a community can help women with Postpartum depression by outreach and providing support that is needed. Where did the idea come from that some pharmaceutical drug can fix things? They have never fixed anything and never will. The quote unquote relief that people receive temporarily from these drugs is never worth the risk. I speak from first hand knowledge, and if women are prescribed this drug they will end up damaged and/or dead from the effects of the drug on the body and possibly by suicide. There is no place for the use of Benzo’s outside of a closely medically monitored environment.
Please disregard my comment. I was didn’t read before commenting I went based on what I heard. After reading I would have commented a bit differently but I still do not approve of this medication.
How does this effect the suckling child?
When people are in an uproar over the cost of insulin and other life saving medicines, I find it a tad arrogant to list the price of this med at $34,000. Will anyone actually pay that much? Not once the activists force it to be covered by insurance, which they will. But as in everything covered by insurance, we will ALL pay for it by increased premiums, higher copays and coinsurance. Now let’s add the cost (and time commitment) of 60 hrs in the hospital and the only women who are going to use this medication are already well-to-do, women who already have access and no time constraints to nonmedical treatments such as yoga and meditation.
Is there a need for safe, effective meds for treatment of PPD? Yes. Are there meds out there that have been useful? Yes (some even generic). But they are not officially approved. That takes time and research, something no pharma company is going to invest in when a drug is near the end of its profit life span. So the research falls to NIH or NIMH, oh wait. Trump wants to reduce funding to those unbiased, research organizations.
And now you know, in a thumbnail sketch why pharma releases new meds with borderline efficacy at HUGE price tags. The system is set up so they can!
No comment is complete these days without some mentioning Trump. TDS.
Excuse me. I cannot find any published paper describing the trial. I did find a press release. This said the trial lasted 30 days and included 151 patients. One patient on drug had to discontinue due to un-described side effects.
Game changer? How would one know? What game? Con game? Certainly not a science game.
FYI
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31551-4/fulltext
The drug’s name is brexanolone. To be added to the long list of compounds, not protected by patent (like Firdapse), that could be bought in bulk for little money from chemical suppliers.
You are sooo correct!! there were 2 trials. In trial 2 PLACEBO was better than drug at 30 days.
Table 2. The text doesn’t report this. It says “These significant increases in CGI-I response occurred as early as 36 h and were sustained at day 7. But the protocol called for analysis at 30 days. The 30 day data was noted for the study where there was a small but stat. sig effect in favor of drug. Somehow the authors failed to write up the 30 day data. (Its in the graph). So as is typical of industry studies the results are intentionally spun to help sales not patient care.
If a student of mine did this I would fail them for an ethical violation. Lets see what UNC does.
Sounds great until I saw the price tag. Hopefully it will come down with time. In the meantime, any good functional medicine physician can most likely guide you to helpful supplements. Through Groupon and Meetup, you can explore meditation, yoga and sound therapies (like the gong bath shown in last weeks episode of Greys Anatomy) to help reboot healthy pathways and help
get your neurotransmitters working in harmony. Sounds crazy. Tried it a month ago. Well worth a shot.
Outrageous. They are going to hospitalize new moms and charge $34,000 plus hospitalization costs for a drug that barely works better than a placebo. How did this get approved? Birth control pills (skipping the placebo week) to even out the mood swings and anti anxiety meds as needed are quite effective for PPD. But there’s no profit in promoting cheap existing drugs.
Agree- how about providing these women with some natural progesterone, the hormone that takes a severe dip after childbirth. Oh wait, big pharma wouldn’t profit.
What of toxicity to a baby nursing?
A brilliant example of how the FDA is promoting the approval of fake and/or worthless medicines.
Two thirds of the drug effects can be ascribed to a placebo effects. That is, only a minor fraction can be ascribed to the drug. And considering the burdensome administration protocol, it is hardly justifiable. In addition, the placebo effect is consistently long lasting, supporting the view that postpartum depression is mostly a psychological affliction, rather than physiological.
“the view that postpartum depression is mostly a psychological affliction, rather than physiological…”
I’m going to be immature here, but HAHAHAHAHAHA! Spoke like someone who has never experienced the hormonal whiplash and insane physiological changes that accompany pregnancy, birth, and the postpartum experience.
Certainly there are psychological aspects to most forms of depression, but the idea that severe PPD is not physiological is laughable.
the consideration comes from the results of their own clinical trial.
Not from your single personal experience, Genius!