Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
MemberI believe they are interlinked. So I'm guessing but I would wager it would work for both.
ruben ruiz
Member
Well, there's this deaf person whose had tinnitus for like 30 years and he only has a skin graft in his ears and nothing else. I think Autifony are on the right track and understand it's a brain issue first and foremost.
Dubbyaman
Member
hey dan, does trobalt take the sound down? is there any cases where it has woeked for noise induced t?
It works for noise induced tinnitus and it does reduce tinnitus for me and a few others. I can't comment if it will work for you, as everyone is different. I only recommend it as a last line drug and shouldn't be used if you can manage your condition.
- Apr 30, 2014
- 533
- Tinnitus Since
- 04/2014 (many increases since then)
- Cause of Tinnitus
- Progressive hearing loss / noise / ETD
For those of you wondering why exactly these trials took so long to get going.
http://quest.mda.org/article/why-does-it-take-so-long-go-mouse-man
After all that and most sites I've looked at say that most drugs that go all the way through trials take 3 to sometimes 10 years (depending on what the drug is for. i know drugs on trial for cancer take an insane amount of time) and then they have to pass a bunch of tests by the FDA, MHRA, etc...
In other words it's going to be a really really really long while.
Lets just hope that we all survive that long
http://quest.mda.org/article/why-does-it-take-so-long-go-mouse-man
After all that and most sites I've looked at say that most drugs that go all the way through trials take 3 to sometimes 10 years (depending on what the drug is for. i know drugs on trial for cancer take an insane amount of time) and then they have to pass a bunch of tests by the FDA, MHRA, etc...
In other words it's going to be a really really really long while.
Lets just hope that we all survive that long
Dubbyaman
Member
Ever since I got it, it has fluctuated. I have loud days and quiet days. I went to see a tinnitus specialist and he recommended baclofen, a muscle relaxer nut i dont trust it due to the lack of success stories ive read which are NONE. Im just so tired of this noise.
For those of you wondering why exactly these trials took so long to get going.
http://quest.mda.org/article/why-does-it-take-so-long-go-mouse-man
After all that and most sites I've looked at say that most drugs that go all the way through trials take 3 to sometimes 10 years (depending on what the drug is for. i know drugs on trial for cancer take an insane amount of time) and then they have to pass a bunch of tests by the FDA, MHRA, etc...
In other words it's going to be a really really really long while.
Lets just hope that we all survive that long
This drug will be fast-tracked as it meets the need of an unmet medical condition.
For those of you wondering why exactly these trials took so long to get going.
http://quest.mda.org/article/why-does-it-take-so-long-go-mouse-man
After all that and most sites I've looked at say that most drugs that go all the way through trials take 3 to sometimes 10 years (depending on what the drug is for. i know drugs on trial for cancer take an insane amount of time) and then they have to pass a bunch of tests by the FDA, MHRA, etc...
In other words it's going to be a really really really long while.
Lets just hope that we all survive that long
Luckily we are NOT dealing with the FDA ! So your link does not apply to Autifony which is a UK drug in development.
- Apr 30, 2014
- 533
- Tinnitus Since
- 04/2014 (many increases since then)
- Cause of Tinnitus
- Progressive hearing loss / noise / ETD
Yes but so far, every time I've heard you say it's going to be fast tracked, there has been someone to prove that idea wrong. Plus (at least with the FDA) there's a difference between fast tracking a drug and putting it through accelerated approval: http://www.fda.gov/forpatients/approvals/fast/ucm20041766.htm
Also the MHRA has slightly different but similar guidelines for their fast track program: http://www.pharmatimes.com/article/07-07-11/MHRA_sets_out_terms_for_fast-track_evaluations.aspx
And since Autifony has not said whether they will put their drug through fast track through the MHRA or the FDA or any other country's system, we cannot faithfully say that it will be fast tracked. For all we know the people in charge of evaluating these drugs could consider (like much of the rest of the world that doesn't care about us) tinnitus to be non urgent and non life threatening.
Just because it says "However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account," does not mean it will most certainly be fast tracked. The people at Autifony know how much we need SOMETHING to help us. But it is not guaranteed that others will be of the same mindset.
Not trying to be a downer but people need to understand that IF and ONLY IF this drug works, it will still be a very long wait. Instead of pushing hope onto this and making patience levels go down, we should be actively trying to find other ways to help and comfort each other.
I too hope that this drug will work but I am not counting on it.
Also the MHRA has slightly different but similar guidelines for their fast track program: http://www.pharmatimes.com/article/07-07-11/MHRA_sets_out_terms_for_fast-track_evaluations.aspx
And since Autifony has not said whether they will put their drug through fast track through the MHRA or the FDA or any other country's system, we cannot faithfully say that it will be fast tracked. For all we know the people in charge of evaluating these drugs could consider (like much of the rest of the world that doesn't care about us) tinnitus to be non urgent and non life threatening.
Just because it says "However, an effective drug for tinnitus is critically needed and the regulatory authorities who approve medicines for marketing are aware of this and would take matters into account," does not mean it will most certainly be fast tracked. The people at Autifony know how much we need SOMETHING to help us. But it is not guaranteed that others will be of the same mindset.
Not trying to be a downer but people need to understand that IF and ONLY IF this drug works, it will still be a very long wait. Instead of pushing hope onto this and making patience levels go down, we should be actively trying to find other ways to help and comfort each other.
I too hope that this drug will work but I am not counting on it.
- Aug 21, 2014
- 5,049
- Tinnitus Since
- 1999
- Cause of Tinnitus
- karma
if this gets faster regulatory approval in the UK than in the US, then it will be in the situation of being a drug which is not on the books in the US at all, meaning it's legal to import -- if you can get someone to sell it to you to begin with in the UK, which may be hard.
@derpytia, I agree with you that we should be cautious about putting all our eggs in the autifony basket:
* we won't know if the drug works in the clinical trials for a year
* if it works in the clinical trials, we won't know if it actually works until it's on the market for some time; for-profit drug trials are absolutely notorious for showing greater efficiency and safety than is actually the case in a real patient population
* there's no good reason to expect that this will be available on the mass market until 2018/2019/2020. Even having it in widespread use in 2020 would represent a relatively fast path to market, all things considered.
@derpytia, I agree with you that we should be cautious about putting all our eggs in the autifony basket:
* we won't know if the drug works in the clinical trials for a year
* if it works in the clinical trials, we won't know if it actually works until it's on the market for some time; for-profit drug trials are absolutely notorious for showing greater efficiency and safety than is actually the case in a real patient population
* there's no good reason to expect that this will be available on the mass market until 2018/2019/2020. Even having it in widespread use in 2020 would represent a relatively fast path to market, all things considered.
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
So, if Autifony is a bust and it's found that it doesn't work as anticipated, what else is in the pipeline?
Not much else in the near or not-so-far future in regards of long term tinnitus I'm affraid.
SF34 would be my guess, which is still very far away.
noisebox
Member
- Jul 4, 2015
- 319
- Tinnitus Since
- 04/2012
- Cause of Tinnitus
- West End show. Came back 2015 vitamin D overdose prescribed
A person on here who saw the neuro otologist in Sheffield who is running the trial said to her ' if it works we will market in 2 years'
Surely this person meant they will be starting the marketing process in 2 years if the drug works at all.
I don't know if a doctor running a blinded trial is qualified to make statements about Autifony's next steps. Doctors should keep to doctoring.
As I keep saying, they will fast track it within the UK. Let's just say I already know and don't need to say why or how. Just that I know.
Even if it is fast-tracked there is absolutely no way we will be able to buy AUT00063 pulls in a pharmacy in 2 years, which was my response to sailboardman's comment.
http://www.nhs.uk/news/2014/03March/Pages/New-fast-track-drug-scheme-to-help-severely-ill.aspx
"'Early access' drugs scheme launched for severely ill," BBC News reports.
The government has launched the Early Access to Medicines Scheme designed to help patients with life threatening or debilitating conditions get access to unlicensed medications that could potentially be of benefit.
How are drugs currently regulated?
In the UK, drugs need to gain a marketing authorisation, sometimes called a licence, before they can be used to treat patients. This licence specifies what condition(s) the drugs can be used for. To get this licence, the manufacturers must provide evidence that their drug has been shown to be beneficial in clinical trials (usually phase III clinical trials) and is sufficiently safe to allow wider use among people with that particular condition. This process of testing drugs and then applying for a licence takes a long time – sometimes up to a decade – and not all drugs are successful.
Healthcare professionals can already prescribe unlicensed drugs if there is no suitable licensed alternative and they judge that the drug is likely to benefit the patient. They need to follow professional guidance for this type of prescribing, and there are regulations guiding how the drugs are made and imported. Drugs prescribed in this way may have already received a licence for use in another country (for example the US), but not in the UK.
What role does the MHRA play?
The Medicines and Healthcare Products Regulatory Agency (MHRA) is a Department of Health agency that assesses whether drugs are sufficiently effective and safe to be granted a licence for use in the UK. Drugs can also be granted a licence for use in all European Union (EU) and European Economic Area (EEA) countries through a similar assessment performed by a centralised organisation called the European Medicines Agency (EMA).
What changes have been announced?
A new scheme – the Early Access to Medicines Scheme (EAMS) has been set up to allow patients who have life threatening or seriously debilitating conditions to get access to drugs at an earlier stage in their development than they would normally be available, and before they have been granted a licence. There also needs to be a medical need for these drugs, either because there are no other treatments available or the available treatments are not suitable (for example if the person has not responded to them).
How will the Early Access to Medicines Scheme work?
A drug will have to pass through two stages to be part of the EAMS scheme:
The MHRA will assess the balance of benefits and risks, and issue a summary of its findings and its scientific opinion on these. This will allow healthcare professionals and patients to make more informed decisions about whether the drug is appropriate for them. Drugs being prescribed under this scheme have to be provided free of charge by the manufacturer.
The scheme does not replace the normal licencing process, but the early access scheme could allow access several years before the formal licence is granted. For example, the drug could be made available after phase II trials while phase III trials are still ongoing.
When are the changes come into effect?
The Early Access to Medicines Scheme is scheduled to launch in April 2014. At this point, companies can submit applications to the MHRA for their drugs to be considered for the scheme.
What has been the reaction to the news?
Drug companies and patient groups have mainly reacted positively to the launch of the scheme. The BBC quotes the chief executive of the BioIndustry Association, Steve Bates, who said: "(the launch) shows the UK is committed to an 'all hands on deck approach' to speedily progress promising innovative therapies to the patients that need them."
Echoing this, Harpal Kumar, chief executive of Cancer Research UK, said: "Time is of the essence for many cancer patients, particularly those with more advanced disease.
"It can mean the difference between life and death. Therefore this scheme, which has at its heart the potential to bring promising new medicines to patients faster, is to be warmly welcomed."
However, reaction has not been universally positive. The Faculty of Public Health at the Royal College of Physicians has apparently warned that the scheme could expose vulnerable patients to untested medicines that could shorten, rather than lengthen, their life.
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter. Join the Healthy Evidence forum.
"'Early access' drugs scheme launched for severely ill," BBC News reports.
The government has launched the Early Access to Medicines Scheme designed to help patients with life threatening or debilitating conditions get access to unlicensed medications that could potentially be of benefit.
How are drugs currently regulated?
In the UK, drugs need to gain a marketing authorisation, sometimes called a licence, before they can be used to treat patients. This licence specifies what condition(s) the drugs can be used for. To get this licence, the manufacturers must provide evidence that their drug has been shown to be beneficial in clinical trials (usually phase III clinical trials) and is sufficiently safe to allow wider use among people with that particular condition. This process of testing drugs and then applying for a licence takes a long time – sometimes up to a decade – and not all drugs are successful.
Healthcare professionals can already prescribe unlicensed drugs if there is no suitable licensed alternative and they judge that the drug is likely to benefit the patient. They need to follow professional guidance for this type of prescribing, and there are regulations guiding how the drugs are made and imported. Drugs prescribed in this way may have already received a licence for use in another country (for example the US), but not in the UK.
What role does the MHRA play?
The Medicines and Healthcare Products Regulatory Agency (MHRA) is a Department of Health agency that assesses whether drugs are sufficiently effective and safe to be granted a licence for use in the UK. Drugs can also be granted a licence for use in all European Union (EU) and European Economic Area (EEA) countries through a similar assessment performed by a centralised organisation called the European Medicines Agency (EMA).
What changes have been announced?
A new scheme – the Early Access to Medicines Scheme (EAMS) has been set up to allow patients who have life threatening or seriously debilitating conditions to get access to drugs at an earlier stage in their development than they would normally be available, and before they have been granted a licence. There also needs to be a medical need for these drugs, either because there are no other treatments available or the available treatments are not suitable (for example if the person has not responded to them).
How will the Early Access to Medicines Scheme work?
A drug will have to pass through two stages to be part of the EAMS scheme:
- being designated as a "promising innovative medicine" (PIM)
- being given an official opinion on whether it can be provided under EAMS
The MHRA will assess the balance of benefits and risks, and issue a summary of its findings and its scientific opinion on these. This will allow healthcare professionals and patients to make more informed decisions about whether the drug is appropriate for them. Drugs being prescribed under this scheme have to be provided free of charge by the manufacturer.
The scheme does not replace the normal licencing process, but the early access scheme could allow access several years before the formal licence is granted. For example, the drug could be made available after phase II trials while phase III trials are still ongoing.
When are the changes come into effect?
The Early Access to Medicines Scheme is scheduled to launch in April 2014. At this point, companies can submit applications to the MHRA for their drugs to be considered for the scheme.
What has been the reaction to the news?
Drug companies and patient groups have mainly reacted positively to the launch of the scheme. The BBC quotes the chief executive of the BioIndustry Association, Steve Bates, who said: "(the launch) shows the UK is committed to an 'all hands on deck approach' to speedily progress promising innovative therapies to the patients that need them."
Echoing this, Harpal Kumar, chief executive of Cancer Research UK, said: "Time is of the essence for many cancer patients, particularly those with more advanced disease.
"It can mean the difference between life and death. Therefore this scheme, which has at its heart the potential to bring promising new medicines to patients faster, is to be warmly welcomed."
However, reaction has not been universally positive. The Faculty of Public Health at the Royal College of Physicians has apparently warned that the scheme could expose vulnerable patients to untested medicines that could shorten, rather than lengthen, their life.
Analysis by Bazian. Edited by NHS Choices. Follow Behind the Headlines on twitter. Join the Healthy Evidence forum.
UK to fast-track some drugs under early access scheme
LONDON | BY BEN HIRSCHLER
Britain is to accelerate access to ground-breaking drugs for serious conditions under a new early-access plan that the government hopes will benefit both patients and pharmaceutical companies.
The initiative, which has similarities with a U.S. scheme that has speeded the development of so-called "breakthrough" medicines, follows criticism that Britain's state-run healthcare system is too slow to adopt new medical treatments.
The Early Access to Medicines scheme, which was unveiled on Friday, will mean that patients with life-threatening and debilitating diseases may get access to novel medicines months or even years before they are officially licensed for sale.
Doctors will be able to prescribe promising new drugs as soon as the Medicines and Healthcare Products Regulatory Agency - the country's drugs watchdog - signals that the benefits outweigh the risks, following an initial scientific assessment.
The programme will be funded by drug companies. That is a bonus for the country's National Health Service, will which not bear any extra costs, but it is a bone of contention for the industry, even though companies overall applauded the plan.
Health minister Jeremy Hunt said the scheme would help make Britain a leading location for life sciences and drug development, and should create more jobs by encouraging firms to carry out more work in the country.
Pharma has traditionally been a key plank of the British economy, thanks to the presence of local groups such as GlaxoSmithKline and AstraZeneca, and the presence of laboratories operated by several international players.
But recent cutbacks, including Pfizer's decision three years ago to close its large R&D site in Sandwich, southern England, have dealt a blow to the sector and worried the government. That prompted a pledge by Prime Minister David Cameron in 2011 to improve early access to key new drugs.
The new scheme will be launched in April. Medicines deemed suitable for inclusion will be given a Promising Innovative Medicine designation, which could occur several years before licensing.
Although companies will have to fund early access out of their own pockets, they will gain valuable experience about drug use and be able to build up awareness of new medicines among prescribing doctors.
The Association of the British Pharmaceutical Industry welcomed the initiative. However, trade body said the lack of central funding was a concern and it asked that the scheme be reviewed after the first year to look at funding options.
LONDON | BY BEN HIRSCHLER
Britain is to accelerate access to ground-breaking drugs for serious conditions under a new early-access plan that the government hopes will benefit both patients and pharmaceutical companies.
The initiative, which has similarities with a U.S. scheme that has speeded the development of so-called "breakthrough" medicines, follows criticism that Britain's state-run healthcare system is too slow to adopt new medical treatments.
The Early Access to Medicines scheme, which was unveiled on Friday, will mean that patients with life-threatening and debilitating diseases may get access to novel medicines months or even years before they are officially licensed for sale.
Doctors will be able to prescribe promising new drugs as soon as the Medicines and Healthcare Products Regulatory Agency - the country's drugs watchdog - signals that the benefits outweigh the risks, following an initial scientific assessment.
The programme will be funded by drug companies. That is a bonus for the country's National Health Service, will which not bear any extra costs, but it is a bone of contention for the industry, even though companies overall applauded the plan.
Health minister Jeremy Hunt said the scheme would help make Britain a leading location for life sciences and drug development, and should create more jobs by encouraging firms to carry out more work in the country.
Pharma has traditionally been a key plank of the British economy, thanks to the presence of local groups such as GlaxoSmithKline and AstraZeneca, and the presence of laboratories operated by several international players.
But recent cutbacks, including Pfizer's decision three years ago to close its large R&D site in Sandwich, southern England, have dealt a blow to the sector and worried the government. That prompted a pledge by Prime Minister David Cameron in 2011 to improve early access to key new drugs.
The new scheme will be launched in April. Medicines deemed suitable for inclusion will be given a Promising Innovative Medicine designation, which could occur several years before licensing.
Although companies will have to fund early access out of their own pockets, they will gain valuable experience about drug use and be able to build up awareness of new medicines among prescribing doctors.
The Association of the British Pharmaceutical Industry welcomed the initiative. However, trade body said the lack of central funding was a concern and it asked that the scheme be reviewed after the first year to look at funding options.
- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
Someone needs to go full Breaking Bad and develop a superlab to pump out these pills for people who want to use them.
- Jan 3, 2015
- 635
- Tinnitus Since
- 04/21/2014
- Cause of Tinnitus
- Sensorineural hearing loss right ear.
DB. Am I correct in stating that, Autifony has not entered into phase III clinical testing as yet? And if so, wouldn't it be safe to say, we are still, at least, 7 years away from a marketable product? That's again if it shows significant results, after phase III testing.
I know everyone here has postulated that, 00063 is the magic drug, that may or may not cure/reduce T. My question was, what's being worked on now, if 00063 fails to miss the mark? Will we be thrown back into the dark ages again, hoping for yet another treatment, before we go insane or better yet die? Nobody on this forum, can answer this question, I know.
I know everyone here has postulated that, 00063 is the magic drug, that may or may not cure/reduce T. My question was, what's being worked on now, if 00063 fails to miss the mark? Will we be thrown back into the dark ages again, hoping for yet another treatment, before we go insane or better yet die? Nobody on this forum, can answer this question, I know.
Log in or register to get the full forum benefits!
Similar threads
