Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
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This makes me think of the human dream of immortality (at least many people's dream). It would simply be too much. Just imagine being immortal and having T. and then having it worsen as the years go by. What a nightmare!
Really, so did you try Trobalt yet? Or have you decided wait 2 more years+ for Aut?
The drug can come to the market before the phase III is finished through so called New Drug Application. That allows the drug to be sold on the market while the phase III study is ongoing. However the drug must be pulled off the market if any adverse effects are reported anywhere.
Most pharmas don't do this but it's not that uncommon either that drugs undergo phase III trials in the market.
So AUT00063 might not be that far away. It depends on the outcome of the phase II and how Autifony wants to do it with their drug.
I really hope so! Well, could come out next year! It seems like a safe drug after phase 1.
We better hope first that the drug goes to phase III. Only 18% of all drugs go from phase II to phase III. Also phase III is the most expensive one to preform.
We can be really hopeful! I think Autifony will be successful! Wish I could've have tried it.
Is this a fact? What are the requirements that authorities will allow such a thing? If this really is true, it would be awesome.
This does not seem to be the norm though.
It is common practice that certain Phase III trials will continue while the regulatory submission is pending at the appropriate regulatory agency. This allows patients to continue to receive possibly lifesaving drugs until the drug can be obtained by purchase. Other reasons for performing trials at this stage include attempts by the sponsor at "label expansion" (to show the drug works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing), to obtain additional safety data, or to support marketing claims for the drug. Studies in this phase are by some companies categorized as "Phase IIIB studies."[7][8]
While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate regulatory agencies such as FDA (USA), or the EMA (European Union)
Once a drug has proved satisfactory after Phase III trials, the trial results are usually combined into a large document containing a comprehensive description of the methods and results of human and animal studies, manufacturing procedures, formulation details, and shelf life. This collection of information makes up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[9] in different countries. They will review the submission, and, it is hoped, give the sponsor approval to market the drug.
- May 7, 2015
- 1,050
- Tinnitus Since
- 29.09/2014
- Cause of Tinnitus
- Acoustic trauma using headphones
Sure would be interesting to look at the comebacks from Autifony based on Tinnitustalks Q&A tread. Anybody knows when we can expect this?
FounderThe questions were sent to Autifony on June 12th. They responded and said they are currently very busy (Autifony is a small team), and are also traveling.
No precise ETA for answers, but I'd guesstimate within 6 weeks. Hopefully, but no guarantees.
We should all be very thankful for Autifony agreeing to the Q&A. Thanks everyone at Autifony!
Yes but then:
"Most drugs undergoing Phase III clinical trials can be marketed under FDA norms with proper recommendations and guidelines through a New Drug Application (NDA) containing all manufacturing, pre-clinical, and clinical data. In case of any adverse effects being reported anywhere, the drugs need to be recalled immediately from the market. While most pharmaceutical companies refrain from this practice, it is not abnormal to see many drugs undergoing Phase III clinical trials in the market."
Can you give examples of such drugs that have been in the market during Phase III trial?
ALL DRUGS HAVE SIDE EFFECTS.
"In case of any adverse effects being reported anywhere, the drugs need to be recalled..."
It's no surprise pharmas don't do this. EVERY drug has adverse effects. It would make no financial sense to do this.
Of course and most of these are brought to knowledge in phase I and phase II. I think that by adverse effects in this case is not headache or cotton-mouth but more things like liver failure, brain damage, blood clotts, death or things like that.
I would've thought it would be much lower. It's very common for new drug candidates to do very good on animal models and fail completely in human trials.
1 in 5. Not completely hopeless.
In any case, the results should be published this fall so we will know soon enough.
I don't think you can draw those conclusions. It was the same thing with AM-101. In the end it showed to be a couple negative reviews from people that probably were on placebo and didn't go through with the trial, that echoed through the forums.
We can't possibly know anything from only 6 people. Even if all 6 out of 6 were positive it's still too little to draw any conclusions. There are hundreds of people in the trial and we have 6 here. And frankly, how the hell can we even be sure that all of these people are in the trial. I'm pretty sure that Autifony won't share that information. And I'm also pretty sure that they don't like their trilees running around on forums like this. I know I wound't if I was trialing a drug since they might interfere with the results and influence other trialees either positively or negatively. Either way is bad for the outcome of the results.
Yes, that is a low percentage but there are all kinds of reasons why drugs don't go to phase III. It could be that the drug has too many or too severe side-effects in which case it can be modified and then re-branded and hit the market some years later when the problem has been sorted out. Another is that a competitor has beat you to it so to speak and it's therefore not worth the money that a phase III trial costs since there now already is a similar drug that works fine out on the market. Remember that phase III is the one that costs the most out of all phases.
There are also other drugs on the way that are entering trials. We have Otonomy that is entering trials. We have AM-102 that is a bit further away but non the less still being worked on. Then there are KV3.1 modulators for epilepsy that are coming out that can be prescribed off label such as Brivarectam that is scheduled for release on the market some time next year.
Don't loose hope so quickly. There is so much that has been done in the last 5 years, it's insane! When I first got this thing in 2006 there was absolutely nothing. There was nothing even being worked on. AM-101 wasn't even in the infant stages and now it's hitting the market probably next year. Be patient. A cure is coming! It's just a matter of time.
And what's great is that even the newsletters from The Hearing Health Foundation nowadays contain information about projects that are working towards a cure like restoration of hair-cells and so on. Back in 2006 they only wrote about hearing-aids and cochlear implants.
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