Gemini translation: I've got a bit of news. I was able to ask some doctor and pharmacist friends if it's normal for a drug with a successful Phase 3 trial to go back and recruit for more trials. They all told me that it's completely normal and even highly recommended. The first successful Phase 3 trial proves that the drug works for a relevant percentage of patients to be approved. It also confirms that the side effects are outweighed by the health benefits. After all, it's not worth slightly improving tinnitus if you go blind as a side effect (a side effect I just made up, don't worry). But once that's accomplished, there are many other things to check for, and these are many other variables. For example: Side effects or impact on more specific groups based on race, sex, weight, age, etc. Checking the effects or incompatibilities with other medications or diseases. (How does the drug act on someone who takes cholesterol pills or insulin?) Strengthening long-term data. Since many patients are impatient and expect immediate improvement, they often drop out of trials, which makes it harder to draw conclusions about a drug's effects over several years. I personally didn't feel anything with betahistine until about 8-9 months, and yet now, every time I try to reduce my dose to see if I can adjust it, I start to feel slightly dizzy, and it's happened several times, so I don't think it's a random Meniere's coincidence. Checking how it works depending on the progression of the disease. Does it work for everyone or just for those who have had Meniere's for a few years? Does it work for those who have had surgery or only for those who haven't? etc. The truth is that investigating various studies on betahistine, this fits quite well. There were never clinical trials where betahistine was 90-100% successful for patients. There were trials with 60% success, but others were 40% or less. However, taking all the trials together, it seems to have a positive effect on a large number of patients, and since no trial showed serious long-term side effects, it was approved in many countries because there is no better and equally safe alternative. SPI 1005 could be similar. If it works for 20-30% of people and doesn't show significant side effects, it might be approved because it's a safe alternative worth trying before gentamicin injections or destructive surgeries. In the same way that we have all tried "safe" things and not gone straight to the operating room: diuretics, diets, lysine, betahistine, antivirals, allergy vaccines, etc.
i’m still skeptical about this drug and the trials. I’m thinking they didn’t get enough people to get a good enough sample to see if the drug was effective . I know at my clinic they wanted 30 people and they only got 23 to start the trial and only three finished. I’m thinking they didn’t get enough people overall to prove the drug really works. I would also assume that if you were in any of the other phases, you cannot sign up for another trial. I guess time will tell.
Hello, The results of other clinical trials I've looked at (betahistine, gentamicin, etc.) don't usually have many more, ranging from approximately 80 to 300 patients. The only Phase 3 trial I know of that used thousands and thousands of volunteers was the COVID vaccines. And that's a different story. Anyway, I guess we're not far from knowing the truth, whether it comes to market or not.
Now on the clinical trial website, they clarify its purpose. To check for long-term damage makes sense because it is a "lifelong" medication.
...and it will end in February 2027. Weren’t Sound Pharmaceuticals going to have a meeting with the FDA at the end of this year?
Who knows what’s really going on-I wonder if they’re just trying to keep something alive that’s already DOA.
Well, if they want to check the long-term effects, it's clear they need a trial that lasts a long time. Although, honestly, I don't know why they didn't just take the people from the previous trial and offer to extend it and continue for longer. By now, they should have had results on side effects at, what, 2 years? Although, maybe they couldn't do it because many people abandoned the treatment after not noticing any results. In any case, all we can do is drink plenty of water, exercise, take betahistine, and keep waiting.
They ran a randomized, double-blinded Phase 3 trial on SPI-1005. The co-primary endpoints were met beyond placebo, which is why the results were considered positive. If the drug were ‘DOA,’ it wouldn’t have cleared both endpoints at the same time. What’s your reasoning for calling it DOA despite the endpoints being met?
Everything I've researched, read, and asked indicates that it's perfectly normal to conduct clinical trials after trial 3 to test for long-term side effects or in specific groups of people (diabetics, pregnant women, etc.). The good news is that if this extension of the study is done, the results of trial 3 were sufficient to continue. If they had been poor or inconclusive, it would have been canceled.
My question as well is how this impacts the release timeline, if anyone has any information. I'm inferring the drug will not be released until after this safety trial is competed (Feb 2027)? Or, would the drug possibly move forward with release for short-term use in conjunction with the trial, and once the safety data is collected, SPI-1005 can then be prescribed for chronic use. I don't know enough about how this works, would that be a possibility?
I am almost glad the drug did not work on me. With all this pissing around I would be back where I started symptom wise, and at my age (74) running out of time waiting to see what happens.
It's a good question, but unfortunately, I have no idea. I suppose that until this safety trial is completed (and until there are others), it won't be accessible through ordinary means. Perhaps there is some way to access the drug through extraordinary means, accepting that it's an experimental treatment and in very serious cases, but no doctor really considers Meniere's disease "too serious" to recommend trying an experimental drug whose side effects are unproven. That's usually done in more extreme cases (cancer, ALS, AIDS, etc.). If you're from the US, look on the bright side: when it's available, you'll have access from day one. In Europe, they haven't yet sent the documentation from the completed trial 3 for our drug agency to review, and from what I've read, it takes an average of two years to approve a drug from the moment they receive the application and documentation. I hope that if it goes on sale in the US, I can get it through some other means.
Are there any participants here from the new Phase III trial who can tell us how it's going? Does anyone know anyone?
For what it’s worth the attached is from a Australian Doctor Antonio Lopez-Escamez Who is doing research on Menieres
"To those suffering ongoing sensorineural hearing loss" this exactly describes the majority of Meniere's patients.
Sound Pharmaceuticals Receives FDA Breakthrough Therapy Designation for SPI-1005 to Treat Meniere’s Disease