AM-101 was never billed as a cure. It's billed as a treatment. Since tinnitus is a subjective condition, if they can show statistically significant subjective improvement vs placebo for AM-101, that is a huge step forward in my opinion. Quieter, less intrusive tinnitus elicits often times much less of the emotional and psychological response which causes people to suffer. Would it be cool if it made some peoples' tinnitus more or less go away? Yeah. Is it reasonable to expect that? No. There are very few cures in the world, but tons of treatments. That's just what this is, is a treatment.
As several other posters have noted, AM-101
appears to be shaping up to be an underwhelming treatment. I can envision a downside to AM-101's entrance into the marketplace. Let's assume AM-101 passes all of the necessary regulatory, investor, and internal hurdles. When a distressed patient newly afflicted with tinnitus consults with an ENT and is prescribed this med, I picture several scenarios.
Certainly, a placebo effect is one potential outcome. Others undoubtedly will be satisfied with the physiological benefits this drug provides. However, for many individuals, another outcome is quite plausible. We all know the overarching expectation in Western medicine: we get sick, we go to a health care provider, we leave with some type of treatment course/ option (meds, surgery, etc.). Somebody does something tangible to help us get better. Having a pharmacological compound injected into one's ear drum would be exactly this -- somebody is doing something about the ringing and that fits this Western medicine narrative. Again, yes, some patients will experience a favorable response to this compound.
Other patients, experiencing no or only slight/ moderate relief, might actually suffer from higher levels of anxiety absent any med administration. This anxiety could stem from the realization the
only medication currently approved specifically for tinnitus does not work for them. This realization could be emotionally devastating as expectations for an effective treatment are crushed. It would be a twin blow. First, these patients must deal with all of the emotional/ cognitive distress that comes with tinnitus -- for some guilt, for practically all, a struggle to understand the cause/ precipitating factor(s), the why now, the why me, etc. Then, these patients must struggle with the "bad luck" of not responding (or not responding all that well) to an FDA approved treatment. Expectations are a powerful thing. Double whammy.
In retrospect, the best thing that happened to me was to hear the truth from my ENT. It forced me to accept my tinnitus. I believe this acceptance has played a positive role in my habituation. He was empathetic, but incredibly realistic. Yes, this same ENT armed with AM-101 in the future could provide his patients with a starkly realistic picture of the drug prior to administration. However, I suspect many patients would not let this information dampen their expectations. I believe AM-101's approval will raise expectations exponentially for many new tinnitus patients. Likely, they will not be versed in tinnitus research and will not have read support board threads on AM-101 that detail research subjects' experiences. Similar to most who have come before them, these patients will visit an ENT with some sense of hope. This hope for many will be bolstered by the prospect of being treated with an FDA-approved drug indicated for tinnitus.
Furthermore, it is hardly a new observation that many tinnitus patients become obsessed chasing a cure. Approving a lukewarm medication for tinnitus, in my opinion, could prolong this chase for many new patients. This clearly could prove to be counter-productive.
There is no doubt some patients will find some level of improvement from AM-101 should it be approved. I am not arguing AM-101 should be scrapped. Also, I am in no way against companies/ research efforts investigating tinnitus treatments. I wholly support these efforts. And while I believe many basic questions surrounding the pathophysiology of tinnitus need to be answered before more effective treatments can be developed, I do recognize there are meds (particularly psych meds) which provide benefit to patients for reasons not fully understood. Forging ahead with potential treatments in the face of unanswered questions is not a bad thing.
However, I seriously question the net benefit AM-101 will bring to the tinnitus community should it be approved.... especially to its newest members.
). The "only" thing that the phase III trial will change is that the study is performed on a larger group (and possibly using bilateral interventions; not 100% sure, however).
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