What is meant by "Pivotal trial"? Does it mean if all goes well, Phase II may be the final phase (i.e. Phase 3) needed for FDA approval and if so, what is the timeline and process from the final phase to the drug being on the market?
Otonomy OTO-313 — Treatment of Tinnitus
- Thread starter Michael Larsen
- Start date
Member- Feb 14, 2020
- 1,630
- Tinnitus Since
- 1-2019
- Cause of Tinnitus
- 20+ Years of Live Music, Motorcycles, and Power Tools
Pivotal is typically the last trial. So, yes.
FDA review (for approval) typically requires pivotal trial data and data from another previous trial. There are normally not 2 pivotal trials.
Pivotal trial = Final trial before FDA Approval is given to a medicine.
Medicines can be released for compassionate/expanded use after Phase II, however this does not mean that they have been given complete/final approval.
My understanding is that traditionally the FDA required 2 pivotal trials for drug approval. A pivotal trial demonstrates efficacy. In recent times however, the FDA has trended toward only requiring 1 pivotal trial. Dr Weber said he thought the Phase II trial of OTO-313 could serve as one of the pivotal trials so I think he's hoping to go to market with OTO-313 after the follow on Phase III study (I'm on my phone now so I can't look up his exact quote).
- Sep 24, 2021
- 12
- Tinnitus Since
- 2021
- Cause of Tinnitus
- unknown, maybe jaw or neck problems
Somewhere I read that there would be an OTO-313 study in Europe. Has anyone got any further information?
PortugalTheMan
Member
- Mar 23, 2021
- 169
- Tinnitus Since
- 01/2021
- Cause of Tinnitus
- Anxiety / Maybe years listening to music on headphones
Can I, being from Portugal, participate in the trial? I have had tinnitus for 9 months without hearing loss up to 8 kHz. I think I could be chosen.
Does this mean anyone from Europe can sign up, or only UK residents? I lived in the UK for 10 years, but I have moved to continental Europe...
Ah, I'm likely excluded because I have bilateral tinnitus (different sounds, but still).
ColinUK
Member
- Sep 13, 2020
- 86
- Tinnitus Since
- 2013 initial, worsened 2020
- Cause of Tinnitus
- Initial Music Gig, Worsened Cinema or possible covid
Really hope future trials might get rid of the unilateral tinnitus requirement and time of onset. I'm just over a year in with bilateral tinnitus. Would be knocking on door otherwise.
True, it's actually complete BS - what if you suffered an acoustic trauma in both ears?
That makes sense, especially considering headphones/concerts.
- Mar 6, 2017
- 778
- Tinnitus Since
- 12/2016
- Cause of Tinnitus
- Shooting/loud noise
I was going to apply for the trial since a site is 1 hour from my house. But remember, they could inject you with a placebo. No point unless you're sure it's the real thing unless you're ok being a test rat. My tinnitus is not my main worry, but I would like to have something at least healing up.
ColinUK
Member
- Sep 13, 2020
- 86
- Tinnitus Since
- 2013 initial, worsened 2020
- Cause of Tinnitus
- Initial Music Gig, Worsened Cinema or possible covid
And this is why the people participating in these trials for the greater good do really deserve some credit.
Without the "test rats" there would be no treatments or cures for anybody for anything.
Imagine if the soldiers on D-Day were like "I'm not storming the beach on the first day! I'm not one of those suckers who are possibly gonna get shot! I'm just gonna wait until it gets all cleared".
- Feb 25, 2021
- 1,133
- Tinnitus Since
- 01/2020
- Cause of Tinnitus
- Noise
I would think the ones getting shot will disagree with your greater good reasoning
"The greater good" is exactly why they did it. That is why they are known as the "greatest generation". They knew the risks but also knew what had to be accomplished. You couldn't get most 18-24-year-olds today to delete their TikTok accounts.I would think the ones getting shot will disagree with your greater good reasoning
Anyway, let's not derail this thread lol.
- Jan 16, 2020
- 436
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
I agree with you wholeheartedly. I would like to extend the theme by saying that there is a strong case for us to organize ourselves so that we donate our cochleas to Science after we have passed on.
So for example the cochlea of Patient A who got some (let's say) OTO-413 shots could be compared with that of Patient B who got FX-322 and compared with the Patient C who we know had tinnitus but got no shots at all.
Ehren M
Member
- Feb 8, 2021
- 125
- Tinnitus Since
- 01/24/2021
- Cause of Tinnitus
- acoustic trauma
I hope you reconsider enrolling in the trial. Here's why:
Even if you get the placebo, your participation would help to get the drug to market sooner.
So if the drug works, you either win by getting the drug early in the study, or if you get the placebo then you win by getting the drug after the study.
Alternatively, if everyone avoids participating in the study then no-one will ever get the drug.
- Jan 16, 2020
- 436
- Tinnitus Since
- 1992
- Cause of Tinnitus
- noise? infection? negative stress? other?
Duh... and more importantly if everyone avoids participating, there won't be a trial...........................................................................................................................................
They only do one ear for control reasons. If you get it in two ears, one could improve more than the other or vice versa. It just makes it hard to get streamlined results if you do two ears.
Uklawyer
Member
- Dec 20, 2020
- 720
- Tinnitus Since
- 03/2020
- Cause of Tinnitus
- Medication - antidepressants
Obviously not because they do it for every trial related to tinnitus or hearing restoration.
I hope Otonomy acquires more data from the Phase II study. I would like to know if OTO-313 works for patients with reactive tinnitus or the type of tinnitus that increases due to external noise.
Some people's tinnitus reacts to certain foods or beverages. Maybe OTO-313 can reduce that? And what about hyperacusis?
I hope they uncover more on those from the Phase II study.
Some people's tinnitus reacts to certain foods or beverages. Maybe OTO-313 can reduce that? And what about hyperacusis?
I hope they uncover more on those from the Phase II study.
TinaRuns
Member
- Mar 30, 2021
- 53
- Tinnitus Since
- 09/2020
- Cause of Tinnitus
- Ear infection / perforation
Am I the only one who would be scared because it seems like just about every drug or even ear procedure has the potential to make tinnitus worse?
I would be terrified to have even a placebo shot into my eardrum (which happens to be made of cartilage because it was a graph replacement after surgery -- so I'm not even sure they could inject my ear).
I would be terrified to have even a placebo shot into my eardrum (which happens to be made of cartilage because it was a graph replacement after surgery -- so I'm not even sure they could inject my ear).
Ehren M
Member
- Feb 8, 2021
- 125
- Tinnitus Since
- 01/24/2021
- Cause of Tinnitus
- acoustic trauma
Nah I'm for sure scared, but I weight that against the sense that I'll be disappointed if I miss my time-window to give this a shot. I'm trying to get enrolled in trials and have now spoken with recruiters at three clinics. They're all telling me I'm too far away from the clinic to trust that I'll return for follow-up trials
The search for a clinic that trusts me continues...
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