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


#21

Yeah hopefully sage 217 will be the price of normal SSRI’s or near enough to that, something everyone can easily get their hands on.


#22

Indeed. The significant cost upfront for Brexanolone is that it has to be administered by a qualifying nurse for 60 hours straight in a hospital setting.

Further, if you’re employed, it’ll be very likely that you will have complete or partial coverage :).


#23

can you explain how Sage would benefit those of us with this anhedonia?

i read a post on how anhedonia is the hardest to treat because it has to do with brain circuit feedbacks or something.

from what i’ve read, the compound nsi-189 seems to be the most promising in reversing anhedonia. maybe Sage can help attack the anhedonia from another angle? please share your thoughts, thanks.


#24

I can’t remember where I read this, but there was an estimate quoted for SAGE-217 being somewhere in the range of a few hundred USD a month when it first comes to market. Easily affordable for the potential benefit. I think this estimate was based on prices of previous mass-marketed anti-depressants when they first came out.


#25

I won’t pretend to be deeply knowledgeable on the science part of things. You’re probably aware of the well documented link between depression and statistically reduced neurosteroids. There’s a publication (done on teenage humans) where the single predictive variable on how intense someone’s anhedonia was how low their allopregnanolone levels were. Google something like “Anhedonia allopregananolone teenager”.

We honestly have no idea how sage-217 will benefit us but the PFS Foundations seems to be monitoring it very closely.

Take care - happy 2019.


#26

lol not everybody who took fin is rich…


#27

Rich? The cost of a monthly vehicle payment would be worth it to many of us to feel like a human being again, if these drugs will indeed have that effect. This is far better than the thousands of dollars some new drugs cost monthly, or the cost of certain HRT regimens.


#28

https://www.ncbi.nlm.nih.gov/m/pubmed/24728651/ This says allo is related in sexual desire as well


#29

@Ozeph


#30

Another quote about allo “neurosteroids may also influence male sexual behavior through GABAA receptors. Allopregnanolone has been shown in male rats to potentiate GABAA channel activity in neurons in the medial POA, a region that also produces neurosteroids and is essential for sexual interest, erection, copulation, and ejaculation (Haage and Johansson, 1999; Uchida et al, 2002; Haage et al, 2005).


#31

Thanks Rmoney96

Sage 217 is basically a more potent form of allopregnanolone which many of us lack. (or a more practical form to administer as a pill)

They are in phase 1 and 2 in the development. Phase 2 has 70% rejection on average and phase 3 has 50% rejection.

So statistically, there is 15% chances that this medicine will be marketed, and it should take at least 5-6 years.

The result would be similar to taking L-dopa if you are demotivated and feel no emotions. It fixes those two things and leave the rest intact.

Allopregnanolone in this super form would fix some of the things we suffer from, and leave others intact. It hard to speculate how much would be fix.

PFS is not a single disease. It has a single cause, which provoked and array of diseases. There won’t be a single pill to fix it in my opinion. Each issues needs its own care.

On another sarcastically humoristic note, they are developing a way to boost the naturally occurring 3α-HSD as it is the natural antagonist to DHT in order to treat… hair loss.

5α-RI (fin) destroyed 3α-HSD production more than it did 5α-reductase and this is why we don’t have allopregnanolone and tetrahydrodeoxycorticosterone anymore, both of which are powerful anti-stress neuro-steroids. And this is why cortisol, epinephrine and nor-epinephrine are out of control (the three stress hormones)

If we were to take this 3α-HSD booster, we would lower our DHT and our Androgen Receptor response. As a bonus, aside from not losing hair, we would start producing allopregnanolone and tetrahydrodeoxycorticosterone again. Ironic it would come from an hair falling treatment again, it goes full circle.

Check here: https://www.hairlosscure2020.com/increasing-3-alpha-hydroxysteroid-dehydrogenase-to-treat-hair-loss/ and here: http://2015.igem.org/Team:Technion_Israel/Project/Overview


#32

5-6 years on the market? i thought it was coming out 2021 at earliest. also, l-dopa doesnt do jack for my emotional blunting


#33

Sage 217 has started stage 3 trial and was awarded breakthrough status by the fda and is expected to be fast tracked for release. Currently expedited 2021.


#34

Ozeph is incorrect.

The final studies in the pivotal studies are expected to be out in 2020 and Sage expects to file for a new drug application in the same year. They are much beyond phase 2 for sage-217 and the PPD indication for sage-217 has already met its primary endpoint. The notion that sage-217 has a “15% chance to be marketing” is not true; perhaps for all drugs that apply to the FDA on average but not sage-217.

Ukguy82 is on the right track with an estimated release date in 2021 if you consider the 8 months the FDA requires to review a fast tracked drug, commercialization, etc.


#35

what does he mean by “rejection rate”


#36

A lot of drugs don’t make it on to the market as they fail during one of the trial stages. So far all the results regarding sage 217 have been positive.


#37

I’m glad to be wrong. It’s good news if we can get this in 2-3 years.

This drug will most likely help for insomnia, anxiety, depression and who knows what other pfs symptoms.

It’s till only half the anti-stress hormone. Lack of tetrahydrodeoxycorticosterone remains unaddressed.

I’ll definitively try Sage 217 but I hope to get my 3α-HSD working normally again so i can produce the two anti-stress neuro-steroids myself.

For a pharceutical company point of view, it’s better to sell a drug that won’t cure the disease and the patient will have to take all his life than one that cures it within a short time.


#38

Hypothetically it will help with the some of the mental sides, yes.

I’m not too familiar with where 3a-HSD is but I thought this was upstream from allo and was needed (in addition to 5ar to synthesize allo). Agreed that DHT will be lower given limitations on 5ar but if we have allo, does this not also produce/stimulate DHT and its precursors through the backdoor pathway?

Although a couple of years away, it’s an exciting prospect.

This drug candidate is not used for PFS - I don’t think Sage Therapeutics is thinking how to market this drug for reoccuring revenues from PFS sufferers.

Hang in there guys!


#39

When they come up with Sage 217, It’s going to be a great news for pfs sufferers who can get it.

I have no doubt it will help.


#40

true but when PFS gets accepted as a real condition, would it not become easy to get prescribed Sage?