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

#41

Sage-217 is looking to be approved for postpartum depression, major depressive disorder, and major depressive disorder co-morbid insomnia.

You will not need PFS to be ‘accepted as a real condition’ - simply tell your doctor that you are feeling depressed and want to try sage-217 (or whatever it’ll be called when they figure out a name).

Be well.

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#42

save like finasteride :joy::sweat_smile: ok was my fault. i cycled finasteride and nobody in the studies done that. so its my fault that im fucked up forever

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#43

Well yes your right finasteride should never have gotten past the drug trial stage and been put on the market. It’s definitely not your fault. I will always be sceptical from now on even if a drug is declared safe by the regulatory authorities like the FDA.

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#44

What is your hope for this drug? It seems as if a lot of people have invested an enormous amount of hope in that SAGE-217 is the thing that makes this forum useless. The complete cure. How close to this goals do you think this drug can take us? Over the finish line?

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#45

This drug won’t be a “cure” for PFS in general. That is clear. For example, in all likelihood it won’t address physical changes like dry skin, muscle loss etc.

The hope surrounding this drug is related to the fact that it increases Allopregnanolone, an important neuro-active steroid. It has been demonstrated that people with PFS and mental symptoms have signficantly reduced Allopregnanolone levels compared to healthy controls. And there is quite a body of literature that shows correlations between low levels of Allopregnanolone and mental disease (e.g. depression, anxiety etc.) . Thus, there is some hope that Sage-217 may alleviate some mental symptoms of PFS.

As said above, there is no indication that it will do anything for physical symptoms. It is also worth noting that not only Allopregnanolone levels are altered in PFS patients, but also those of other neuro-active steroids, their precursors and metabolites. There is a lot going on. Also, there is quite variety between PFS patiens in mental symptoms that cannot be explained by low Allopregnanolone levels alone. Thus, it is unreasonable to expect Sage-217 to cure everyone from all mental symptoms.

It is worth keeping expectations in check. There is a chance that Sage-217 may alleviate some mental symptoms in some patients. That would be progress. And it is worth keeping an eye on it. I certainly will. But I would not have much higher expectations beyond that. For a cure, we have much much more work to do. That’s why everyone needs to support the ongoing and future community projects.

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#46

I wish we could get our hands on some research Sage-217.

Going to be hard for me to wait another two years. I’m already 50% older than when women usually target having babies ( and therefore being married by).

Is there any possibility the foundation could organize a study of this medication for us? Why not get started on that now rather waiting until it’s already on market? I’ve noticed Ganaxolone has been studied for various things for something for like 15 years even though not on market yet.

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#47

I’d be down if there was a way, there has to be somewhere

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#48

@vkg1 i saw in another post that ganaxolone is available for research purposes.

agree on not wanting to wait another 2 years, but idk what else to do. already got fked by fin/dut and now im weary of everything lol

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#49

It’s way too expensive for any normal person to afford, though. No way I could afford it certainly.

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#50

what’s the price you saw?

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#51

It looks like it’s about $20/mg. No idea what the oral dosage needed for efficacy, but seems like we’re probably talking hundreds of dollars per day. Would love if someone could figure out what dosage we would want to try is. I guess for those with some money and facing suicide as only other option maybe it’s something to do cost no object.

Frustrating as hell that there are studies on it dating back over 20 years and it just continues to sit on shelf while thousands getting their lives ruined.

Really wish there was a way to compel drug companies to allocate a portion of their profits to addressing negative consequences of drugs they sell.

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#52

@Iso_fin_doubledamage is making progress with 50mg daily, but ive read people making progress on less

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#53

Sorry, I’m not clear. Are you saying that there are people here who have tried Ganaxolone?

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#54

i apologize, due to my brain fog, i completely mixed up the drugs lol.

no i am not aware of anyone who tried ganaxolone

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#55

It’ll be available soon enough with sage don’t worry

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#56

ganaxolone is already available for research apparently

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#57

It was mentioned that it would be very expensive for one person to take a daily dose at the current cost but I would have no problems pitching in money for someone who wants to try this out. For myself, I think I’m done experimenting until the next set of studies come out.

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#58

right, i was just letting him know it’s apparently available.

agree on experimentation, just going to wait till Baylor study + more studies on Gan

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#59

Zulresso was approved today but won’t be available to market until late June. Apparently the foundation has a list of doctors who are willing to try Zulresso on patients.

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#60

This was the press release:

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