Otonomy OTO-313 — Treatment of Tinnitus

It could be that you may need a mix of FX-322 and OTO-313 to fully get rid of tinnitus.

 

Now the question is, will there also need to be additional studies if this were the case? Like in order to get both, would there need to be further safety and efficacy studies to see if it's okay to get both?

 

I would assume it would be fine but I would get FX-322 first, then wait at least 3 months before getting OTO-313 or FX-322 again. Could be that you may need multiple doses of FX-322 spaced far apart e.g., monthly to have an effect of getting rid of tinnitus permanently.

 

Guys, I think even if OTO-313 is approved by the FDA, it won't help us because it's not designed for chronic tinnitus. Our hope is on FX-322 and OTO-413.

 

The line between chronic tinnitus and acute tinnitus is still somewhat unclear. We don't know how it can help us. We can't "think" about this stuff. We have to wait and see the clinical trial results.

 

I think the testing parameters in the clinical trial are focused more on an early onset because in theory there is a stronger chance of the drug proving to be clinically effective. That does not mean it won’t work for chronic tinnitus.

 

My own theory is very acutely will help most people but chronically will be more variable. I think some chronic people will see benefit. I don't think they would have expanded their trial out to a year (per the earlier press releases) if at 6 months people had less of a benefit.

The data from the first trial does suggest at least severe cases may benefit long term.

 

Well you won the battle, I was blocked from being a part of the trial due to the duration of my tinnitus.

What’s that going to accomplish? Absolutely no results and no knowledge if OTO-313 works or not?

 

How's that our fault? Also, we already went through this, you can re-read the old responses.

 

Are you surprised? You didn’t meet the criteria. Like I said before, you wasted their time!

 

I don’t think one phone call before they even started the clinical trial is wasting their time. I also don’t think telling them that there are plenty of people out there who would enroll in the trial if they extended their tinnitus duration criterion is a waste either. What is a waste is for these companies to have strict inclusion criteria only for them to find out their drug fails in the end. This has happened to just about every hearing loss and tinnitus drug since the dawn of time.

 

What don’t you understand? They want the drug to succeed so they set parameters that will most likely achieve that.

 

If anything, strict exclusion criteria makes the chances for the drug to be successful so much better.

 

Just an update. I completed the screening for the trial. I was not accepted due to being on medication for depression and anxiety. The medications could affect the fMRI results. I also learned why they take right-handed people over left-handed people.

Exclusion criteria: pharmaceuticals.

Looks like you're wasting their time. Maybe they should remove the exclusion criteria and we both could be in the trial.

 

How’s that working out for tinnitus?

 

Dude you have to stop. You didn't get in the trial. I'm sorry but we told you so. Even if you did get in, there was a good chance you would have gotten placebo. Move on.

 

Most trials have not been exclusionary enough; this has created difficulty in finding a drug that actually works. Tinnitus is a symptom; not a disorder. It has a cause. Noise induced tinnitus, drug induced tinnitus, TMJ induced tinnitus, Eustachian Tube Dysfunction induced tinnitus, stress induced tinnitus, bilateral tinnitus, unilateral tinnitus, and so fourth.

If they are going to find a drug that helps at least one of those previously described groups they have to narrow down the inclusion criteria. Drug XX might only help those with noise induced tinnitus. etc.

Remember, a big part of the problem of tinnitus is that it is so broad and can arise from so many pathologies. Many previous studies have included tinnitus sufferers from many groups and as such the drugs effectiveness may have been misrepresented.

 

Yeah it's weird to think it's just completely arbitrary and the companies want to limit their applicant pool for absolutely no reason.

 

Actually it talks about a washout period.

Another update:

They called me back today and I told them I would discontinue my medication and complete the washout period.

I will be participating in the study.

 

If a drug works 100% for acute tinnitus (having lasted less than 6 months), but when testing the drug, the duration of tinnitus is not taken into account, allowing all kinds of people enter, with the vast majority having tinnitus for longer than 10 years, the result will be confusing. They may think that the drug does not work and discard it because it does not work for the vast majority but in reality it works for 100% of people with acute tinnitus.

By trial and error it is very important to establish strict criteria.

 

Hmm, they just wanted me to not have made any changes to my meds in the 30 days before the screening appointment.

 

I have a friend who had breast cancer treatment and they subtyped her *extensively* by what genes she had and what receptors her tumor was positive for and planned treatment accordingly. Her treatment was a success because they knew what drugs would work for her and it was not the "standard" drugs which don't work well for her subtype.

For some reason, when you get to tinnitus, though, people have a very binary "it works for everyone or it doesn't work at all" idea but the etiology and underlying pathophysiology is way too diverse to not have a responder population that doesn't include everyone. And part of getting those treatments out is picking and choosing.

 

Too many fancy words! Drugs either work or don't work, period. Stop trying to woo us with your science talk.

 

Come on, self-awareness is a wonderful human trait. I've been in a torture chamber for two years with catastrophic autoimmune hyperacusis and tinnitus. Does anyone on this site seriously want me to get enrolled as a data point? Oh man, everyone must hate me then. Jesus Christ.

 

You are the kind of person who has no knowledge of science but when you speak you sound like a doctor.

Everything she says is good, and is evident in all fields of science.

I am a student of fundamental mathematics and it is obvious that certain group structure which is applicable to humans have characteristics which work for certain classes and not for others.

Take the example of functions which are not continuous on R but are continuous in C.

 

Bro...

 

To be fair to @thinlay, the sarcasm in @Tezcatlipoca's post is probably only obvious if you have been following other threads.

 

Does anyone know if the placebo is sustained release as well? Because if that is the case, doesn't it seem kind of dangerous to inject something that won't do anything to the ear and could only worsen it? Maybe that is why the placebo had more adverse effects?

 

A lot of times it's saline. It's called a clinical trial. Keyword "clinical."

 

It's probably the vehicle + something else. They can't use saline since it would compromise the blinding of the trials.