Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of ZULRESSO (brexanolone) Injection for Treatment of Postpartum Depression


#1

Hi Friends,

This is a couple of days old but I thought it was worthy of sharing. On Friday, the FDA Advisory Committee voted in favor of Brexanolone/Zulresso/Sage-547 for the treatment of Postpartum Depression. This is the final step before the FDA allows the drug to be on the market in December of this year.

How is this relevant to us?

This is a very similar drug candidate to sage-217 which is undergoing phase 3 studies for both postpartum depression and major depressive disorder. If the data readouts for the sage-217 studies are similar to that of Sage-547, it shows that the FDA is very likely to approve sage-217. The PFS Foundation posted this news as well underlying this important milestone: https://www.pfsfoundation.org/research/

Be well!


#2

Nobody seems to give a shit about this as its not getting much attention from PFS victims…I think this is something that could help with brain hormones and the central nervous system…


#3

What kind of timeline are we talking about. Will it be available in 2019?
Thanks for update


#4

I don’t think that it’s so much of a case of not giving a shit mate.
I think it’s more a case if people giving up hope to a degree as the road is soo long .
I took Finasteride years ago for a total of 5-6 years the side effects hit me straight away but I was told this would all resolve by itself over a couple of months.
When the side effects didn’t stop the obvious answer from everyone was use viagra until things stabilize.
When things didn’t stabilize I found this forum read a few of the posts but didn’t join as i still had hope things would come good by themselves.
Years later after stopping Finasteride only to find out I was stuck with the side effects regardless i carried on taking viagra still in hope that things would resolve which they have not.
I tried a million and one things to turn back the clock but nothing really works.
I eventually joined this forum where i have been able to comfort myself and others and learn a little more as to what has happened to me physically as to why finasteride made me impotent.
Since joining this forum i have seen all sorts of medical and therapeutic promises along with scientific studies but nothing that really hasthe answers.
I don’t mean to seem negative but it has been a very very long road to see practically zero recovery coupled with medical ignorance I have received personally and read countless stories of the ignorance others have faced its very difficult to see an end to this situation.

Personally I think hope is running out for alot of people its a tough situation when your in these shoes I think alot of people are just doing their best to get by as most people have exhausted most if not all hope…
We have all tried so many things and seen so many glimmers of hope only to end up back at the start of the road…

It’s hard to believe that thousands of people been left to suffer with so little medical acknowledgment or help for such a long period of time.
Pfs , pssd, ssri victims this is a sad sickening situation for us all.


#5

I agree…I am physically impotent now not sexually…I can’t do anything anymore and my health is a memory…My body has fallen apart…I think this drug could help though more than some realise…I believe vast majority of side effects are due to brain alterations…Already a lot proved by melcangi and can only speculate about Baylor my guess there are ton gees affected by PFS in different systems and different individuals…I also think they may have discovered more that has lead to delays, a guess possibly RNA methlaytion etc…


#6

So you think that this drug could possibly end all the mystery and misery of finasteride does this include the sexual side effects ?


#7

If the PFS Foundation are pushing this drug then they must understand the mechanism behind PFS.


#8

It you take that into consideration it does come across more positive let’s hope that the studies have revealed more information into the mechanisms.


#9

I am sure it would not end it all but if levels could be returned to normal balance in the brain like Allo, which is what this drug does and also affects Gaba you would see a big improvement in symptoms…You have to remember the brain controls how your body responds to everything, including androgens and the nervous system highly involved in this…Things like breathing, heartbeat, muscle twitching all related to the CNS…Even blodd vessels and sexual function…Look up some of Merck’s vaccine side effects I have seen some post that their autonomic nervous system destroyed by this garbage some cannot not even stand up and have to lay down all the time because they pass out…


#10

RxISK professor says that a drug can have 100 different affects the 1 they want you to know about and 99 they don’t.
I’m beginning to see the logic in this statement.


#11

I think it will have considerable benefit to most people - particularly with the depression/anhedonia piece. Further, I don’t think it would be too much of a stretch to fathom that there may be considerable benefits to our sexual problems either. Even if it helps mentally, that would be a huge win.

I dialed into their investors call for Q3, the latest updates are as follows:

  • Zulresso/Sage-547 to be approved by December. You’ll be able to go to the hospital and get an injection starting in March 2019 for the low, low price of $20,000-35,000.
  • Phase 3 PPD for Sage-217 results: announced January 2019 (2 months).
  • Phase 3 MDD for Sage-217: trial to be initiated sometime this quarter (this month or next month), with results being announced Q4 2019. With positive results and approval from FDA, you’re looking for one more year on top of that before you can get it prescribed to you.

Be well - I’ll make sure to post updates on the forums as they become available so to keep everyone in the loop. :slight_smile:


#12

Thanks for following this closely and updating us!


#13

Yes thankyou with any luck this could be the breakthrough that everyone has been waiting for just a shame that low low price is probably a million times more than most can afford let’s see how available this stuff is next year .
Like the “Be Well” part you threw in their.


#14

20k to 35k is not cheap especially for those of us who are not working.


#15

He was being sarcastic.


#16

$20-35k is a big range.

You can likely forget NHS funding at that price. Especially if your problems can be dealt with via other means.

Still, the price should be undercut in about a decade once a generic version is made available. On the plus side, by then, we’d have a short term view on how good it is.


#17

That price is disgusting, I’d consider 1000 a lot for an injection nevermind 35k :open_mouth: Don’t know why anyone would ever pay that, for the average person that’s almost 2 years work without expenses.


#18

From what I heard the first drug Brexanolone/Zulresso/Sage-547 has to be given on an intravenous drip in hospital and that’s probably what is it making it so expensive. These drugs always start out at a very high price and then the price usually comes down.

Because Sage 217 is taken orally from what I understand, and I’m sure it will be less expensive.


#19

Health insurance probably won’t cover this either because PFS is a not a recognized condition.

I suppose the price wouldn’t be too bad if it actually was a cure and we could all go back to the way we were before we took Finasteride.


#20

To clarify, Zulresso/Sage-547 is not going to be prescribed to men - it’s for postpatrum depression. My point for including a price is that there is no way that anyone suffering from PFS will be able to be prescribed this in the first place. We should be looking forward to the release of sage-217, the very similar oral molecule.

The take away is that if Zulresso is approved by the FDA, then it would appear likely that the FDA will also approve Sage-217, if trial results are comparable. Many are hopeful that the trial results will be comparable given that sage-547 and sage-217 are virtually the same compound (aside from one being an IV and the other being an oral pill).