Otividex Phase 3 initially failed because vertigo episodes in Meniere's are highly subject to the placebo effect and their placebo group saw great gains (because their previous Phase 2 results were so good). They had to restart the trial using different recruiting and a different statistical analysis. We don't see any of that here because the placebo group for OTO-413 didn't improve.
What competition? None of these drugs yet exist in the market.
You're absolutely right. I'm sure they don't care about competition as long as the drug works and works well. It will sell itself if it does.What competition? None of these drugs yet exist in the market.
I honestly don't think speculative potential competition years down the line concerns them as much as the challenge of getting their own drugs out the door.
By "refining study protocol" perhaps they realized they needed to tweak the endpoints to increase their chances of FDA approval.
In this case, how come Frequency Therapeutics was allowed to increase the dose of FX-322 in Phase 2a?
Frequency Therapeutics didn't have to reformulate their whole drug. Otonomy is using an extended release gel, so to change dose (if they wanted to), they would have to reformulate.
Technically, if you count Otovidex for Meniere's, Otonomy is further ahead (and they have a swimmer's ear drug already on the market) since it would be released this year on good Phase 3 data. But definitely Frequency Therapeutics is moving very fast. Very well run company.
You're right but tomorrow isn't guaranteed and suffering everyday with no joy or purpose to life is stupid.
Forgive me, but why single out veterans? Why wouldn't any sensible person not be jaded about regenerative meds? It's 2021. How many years have scientists been working on the eradication of tinnitus? Still no cure. So of course a sensible person doesn't believe. But... humans may learn to fly and alter the genome to regress aging. Hope springs eternal... lol.
To be fair, if you read tinnitus research papers from the 80s and 90s it's interesting to see quite a few of them say one of the main causes of tinnitus is cochlear damage (i.e. hearing loss), and then in the next sentence go on to describe how unfortunate it is that there is no way to regenerate hair cells - synaptic damage was still flying under the radar at the time outside of Liberman - and that subsequently, tinnitus treatments would likely need to target the brain unless regeneration becomes feasible.
Regenerative meds for the ear/cochlea have never been designed with the intention of treating tinnitus. They've always been designed with the intention of restoring hearing first, anything else is a bonus. The same goes for FX-322.
Agree. Vertigo attacks are a nightmare. They need a good therapy for refractory ones.
It's such a shame that it essentially all comes down to money. Research for life changing treatments gets held up while some people have more money than they know what to do with. I fully understand that it's just the reality of it all, but when you think about it it's kind of surreal that promising companies have concerns about funding.
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