There is still Ganaxolone, but who knows when if ever it will come out. It never does, though in principle it should basically be just as promising for us as Zuranolone (Sage 217).
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It’s not so a disaster,sometimes clinical trials fail their objectives but it’s seems that they are gonna carry other one soon.
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Research conducted in 2014 showed that PFS sufferers were low in allopreganalone. This was not immediately treatable. This medication aimed to remedy that. Over six years after this finding was made. As a result this is a big disappointment in my mind.
If research uncovers other deficiencies, chemical or epigenetic, we won’t have the means to be able to treat it, not for a long while. Development of drugs is very expensive and slow. There are many hurdles that need to be overcome. That’s just a fact.
Sage held promise to correct one glaring deficiency that was identified with us all, a deficiency that could go quite a way to explain many neurological effects which many suffered from. We will all be at a detriment if it doesn’t reach the market.
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Are you saying that research is pointless and that we should sit and cry? I was saying that we need to be doing everything we can, each and every one of us, to get more research performed. Not clear what your point is, that’s all.
No, all I’m saying is that this is not, as you say, ‘good for us’. Let’s say things as they are.
Well this is disappointing.
Guys, this was a big unexpected disappointment but this is just another setback. Sage-217 is being tested for other illnesses but it will take time to conduct these studies. All we need is for it to get approved for a single indication and we should be able to get access to it for PFS off-label.
A doctor I know reviewed the results for the depression study and it looked liked 9% of the patients in the test group didn’t appear to comply with the study and take the drug and it would have passed with the results. They also only conducted the study over a 16 day period which is a very short trial and maybe needs more time to work.
Ganaxolone is another option but they are further off in the distance. They have a Compassionate Use policy and may allow PFS patients to use it on an adhoc basis.
We don’t know that allopregnanolone is the answer, but it is worth continuing to pursue. We need to be trying as many things as we possibly can and hopefully something will succeed.
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I looked at the public SEC filing. It mentioned statistical significance from placebo when excluding the 9% that didn’t have enough of the drug in their systems.
It also showed that those with more severe depression had a statistically significant decline in depression score.
Unfortunately, the stock market did not think so favorably
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We don’t know that our problem is allo anyway. All we know is that people with PFS in one small study had low allo. It’s sad that we are waiting for bandaids in the first place. What we need is research to find out what PFS is and therapies to fix it. We don’t know that increasing allo would have given us benefit anyway. What’s sad is how pathetically little research has been done and how complacent we are about that. You are getting depressed about not getting something that might have been a partial bandaid if one little study was correct. Meanwhile, we have had over a decade go by when 50 studies could have been performed and we could be trying all kinds of things for cure.
Levels were almost non-existent. It’s unlikely that such low levels wouldn’t have a serious negative effect, even in an otherwise healthy individual. It is something measurable, which we seem to have a serious deficit of, and, we hoped, a straightforward mechanism to increase allo levels, and thus treat that deficiency.
No, it’s entirely reasonable that people would want treatments that can at least alleviate some of the suffering they face. To the contrary - it would be sad if people would not want any treatment, and instead suffer miserably for an indefinite period of time.
This is a separate issue.
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The fact that it worked better for patients with more severe depression was interesting, however I found it quite disappointing that the mean reduction in the HAM-D score was only 3 points in that (the best case) scenario, as opposed to the earlier trials where there was an average reduction of 7 points.
While it’s impossible to say for sure, and I personally am as apprehensive about Sage as I was when I first heard of it, there is still a possibility it could help PFS patients in some cases.
It doesn’t seem separate to me at all. The reason you are depressed about this one drug that might possibly have been somewhat useful (and probably equally likely to not), is that we haven’t been doing enough to promote research. So all our hopes are pinned to stupid little thing like herbs, one drug for depression, and diet. If we had gotten research going then we might have a cure by now. Without a change in approach we will go to the grave sitting and crying that no one is helping us. Is there a reason why you haven’t done the 23andme?
Yup, diet is a stupid thing…
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The trial failure seems like it was just set up incorrectly?
And they are turning to other tests they have to collect better info?
I was under the impression that big pharma companies can get whatever trial results they want if they pay the right people off.
Some time ago, I got to talk to a neurologist about Zurlesso. He told me that according to him Big Pharma would never have allowed a new class of antidepressants to take away the market from the SSRIs and that surely he would not get the chance to be marketed for MDD. He told me that somehow, Big Pharma would find a way to make it seem ineffective … Today his words came true. The goal of the research is not to find a cure, but to find a drug.
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As I mentioned, that was supposedly from the best case scenario. (i.e. discounting noncompliant people from the trial and evaluating the severely depressed group).
50% of investors dropped their shares so it’s not just the setup. It’s just ineffective in treating Depression.
Can we compare PFS-Allo level to depression levels? Is it the same or ours even lower?
Take out the tin foil from the head guys,sage therapeutics is not a small company or at least they are going to pay the pharmacovigilance as “ritual”.
This will likely affect release date? Or is there possibilities to capitalize on the timing