What is the main focus of the Phase 3 trial? Safety or efficacy? Trobalt had some really nasty side effects which ended up getting it pulled from the market so maybe a Phase 3 is a good thing.
Phase 1 is where safety is predominately tested. Thus this would mean that the treatment would have likely either got canned or been made to fix the safety issues first before it could proceed further if it was deemed to be unsafe at this point.
Somebody more knowledgeable may chime in, but my understanding is that OTO-313 is injected intratympanically post acoustic trauma in order to reduce hyper-activity in some way. While XEN-1101 on the other hand is not meant to be injected into the ear but may reduce the hyper-activity in the brain/auditory cortex/associated pathways. Since tinnitus seems to be a brain problem, while having a peripheral cause, I believe XEN-1101 may help chronic sufferers more effectively than OTO-313, but it's all my speculation and I don't know anything for sure.
I believe it might have hence how I stated that there tends to be an analysis of safety outcomes if it is required.
I don't know what you guys are getting so worked up for, they are targeting epilepsy, not tinnitus. Even if the drug works, it should only work for epilepsy, or not?
Because it is based off another drug that was apparently quite effective for tinnitus but unfortunately had too many side effects and had to be pulled. The idea is that they have tweaked it enough to ditch the side effects but remain effective against tinnitus. I think...
Do a bit of poking on this site for Trobalt. It evidently really worked for some people. It was pulled because of dangerous side effects. Doctors can and do approve drugs for off-label use all the time. With any luck this works as well or better than Trobalt and it doesn't turn you blue.
Yes but how do you know that those side effects were not part of the working formula? Maybe if you remove some of the formula it doesn´t work for tinnitus anymore. Also for how many has it worked? Danny Boy reported that his tinnitus came back after a while.
Of course we don't know whether this will work for tinnitus or not, if it will be more or less effective, or if it will ultimately be approved. I mean right now nothing in this world works which is why I follow these things hoping one of them works out by hook or crook. All we do know is that the previous unsafe version of this apparently did something for some people, so time will tell if this has any use to us at all.
I find your knowledge impressive but I'm kind of cautious by nature. I wait till I see the body-count or the number of people who are cured or the number who show improvement. As a matter of fact just a tiny-little improvement for me to lead a relatively normal life would have me more than satisfied and it would ease the time of the years going by till they get a 100% cure.
As far as I know, Phase 3 is the last one. There is something called "Phase 4", but that's a follow-up of the drug once released.
KNCQ1 Kv 7.1 7.2.
Also its formulation is far more potent than Trobalt. A lot less drug for far more efficacy. This is a critical point. It is not only more selective but is a way more potent at lower doses. Hopefully this will significantly reduce the side effect burden.
Honestly, I don't know. I'd say 2024 before this drug hits the market at the earliest. I researched it comprehensively prior to my MEM diagnosis. The presentations on their website are excellent. 20 mg is the dose they are targeting but off label for tinnitus, who knows? The only evidence we have is that Trobalt worked for some plus it ties in with Dr. Susan Shore's hyperexcitability theory.
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