Any news about SPI 1005?

Prolonged inflammation is generally our enemy regardless of the cause. It's a normal body response to injury, but when that source of injury is chronic we run into all sorts of issues. Ebselen is a new anti-inflammatory that can do exactly what you describe - remove the inflammation which gives our bodies a chance to function normally. Of course, it's not addressing the root cause.

One thing I haven't seen in any of my reading is whether someone who's had symptomatic relief with Ebselen didn't have success with Prednisone or another corticosteroid. I'd be curious about that.

 

We shall see what the future brings for this drug. One thing to note, several people on other forums did not have success while on the study drug till the third month. One has almost alleviated all symptoms.
I have so many potential causes of M.D..
Father had it, ruptured eardrum in 82', 108 degree temp in 90' from gangrene appendicitis, TMJ, concussion w/broken jaw (bad ear side), broken amalgam fillings,etc. Hahaha the list is long! That said, I am looking forward to my turn with the real drug. I have been in Meniere's chaos with debilitating dizziness, aural fullness, tinnitus etc.. Yesterday was the worst. Friend took me to appointment in morning. Stopped at market and didn't make it 20' before I was hanging onto the cart and back to car. That afternoon, my first hardcore vertigo attack in months. Only thing I can think of is we have been in big thunderstorm status everyday for last month. I have been dealing with this for 6 years and counting. I am thankful that I got into the study and look forward to seeing what future months bring. I wish all of you a great and blessed day.

 

Yes, for some relief is swift and other it's takes time for the body to recover. I'm excited as well, I just hope I tolerate it well, but I have no reason to believe that I won't. I'm back to Florida in 5 days - 5 weeks until the real drug!

 

I have had so many things done to me drug wise, I think I will tolerate it as well. Time will tell. Safe travels to Florida my friend!!

 

I had success w/ Prednisone decreasing or resolving symptoms in the early years of my MD, however, in the last 2-3 it does almost nothing. I did have a tinnitus volume flare (it got really loud) in March this year, so found my stash of Pred & took 60 mg w/o relief. The next day I took 50 mg, & at some point I noticed the volume level had decreased. Not sure if it was the Pred or a natural decline in the decibels, but it could have been the steroid.

 

Thanks for this. I'm curious if SPI-1005 would work for you similar to how Prednisone used to work. Perhaps in the not so distant future we'll find out.

 

I would think that was the Prednisone, as a) 60mg is a potent dose, b) it can sometimes take up to 24 hours to show effect, and c) if it was just a tinnitus flare without a noticeable hearing loss, that suggests to me that the inflammation was perhaps somewhat mild. But indeed, perhaps it was a natural decline.

Did you take 60mg for just one day and then immediately start the taper? Do do you this often if you see no benefit to mitigate unnecessary side effects?

 

It was just a tinnitus flare. My hearing is gone in that ear except for tinnitus & clicking from MEM & hyperacusis w/
LOUD sounds/noise (I always have earplugs w/ me) so I no longer have changes in hearing w/ tinnitus ramps up.

Re: Prednisone, I learned long ago, when I still had hearing in that ear, when my tinnitus flares, hit it hard w/ a high dose of Prednison (50-60mg) for 1-3 days. My ENT told me I didn't need to taper if I was using it for short duration like that, & I never had a problem stopping it cold. I can only speak for myself on this front as I know we all respond differently to the meds we take. I do get bad side effects from Prednisone even taken short term so I'm happy to be able to stop it abruptly after it does its job.

 

For those that have not read the latest from Sound Pharma in regards to SPI-1005:
Sound Pharma completes enrollment in pivotal Phase 3 clinical trial of SPI-1005 for the treatment of Meniere's disease involving hearing loss, tinnitus, and dizziness.

 

Hi folks, here's my 58 day update. My words in noise test we markedly better this time which was nice to see. I wouldn't call it good, but relative to what it was 58 days ago there was an improvement. 58 days ago (pre placebo or drug) my bad ear was useless in that test. I couldn't even guess at one word. 28 days ago (after placebo or drug), I was clearly taking some good guesses. At day 58, I went deeper into the test and unequivocally knew words when I heard them. I'm also going deeper into the test with my good ear (I'm bilateral). My hearing test was also "smoother" in both ears - instead of spikey it was consistent across frequencies. Also, I have less frequency distortion and annoyance. All positives for quality of life.

I have been taking Famciclovir for about 4 months now, and started to take LDN (low dose naltrexone) about 4 weeks ago. I'm doing a lot of things and I know that it will make it difficult to determine what is working. One thing that started to change about 1 months ago (3 weeks into the placebo or spi-1005) was a marked decrease in my tinnitus. I also have eustachian tub dysfunction in both ears and that has subsided dramatically - I can actually swallow with drama. It seems to coincide with the LDN dosing and I have to say I'm enjoying the effects of that even from a mental capacity. It's helped smooth out my moods and anxiety.

I start taking the real SPI-1005 on July 12th.

 

glad to hear it is working for you. I am on day 42 of the real drug and the only change so far is worsened tinnitus..

 

I don't know if SPI-1005 is working. Something has changed though, however, small it might be. I'm trying to focus on the wins these days!

 

Awesome! A win is a win, regardless of the size.
Had my hearing test today as well. About the same as last month. I figured it would be, as I have been in a bit of chaos for awhile now. I am ecstatic that the next trip will come home with the real drug! I did start the amalgam removal process this week. Argh ...

 

A positive change is a positive change no matter how small!

 

I'm sorry to read that your feeling worse on the real drug. That's definitely the wrong direction. How long are you required to take it or can you stop at any time?

 

I can stop anytime I want, but then I am out of the study I would assume. I'm not quitting now, I have come to far and I hope that things will improve at some point. Plus, everyone in the study is contributing to the hopeful release of this drug to the public and any and all input will help to that end.

 

I'm glad you're in for the long haul, yellowboy. I'm sure every person who takes this medication will be on a different timeline for it to be effective or not. Some may get immediate results, others will need to take it for some months to realize improvement, & some may not get improvement. I'm hoping it will become effective in helping you over time.
I'm thinking of making an appointment w/ my ENT to discuss Ebselen (now that I have a name for it & more info) to see what he knows. He is known by some pretty "nationally ranked" ENT surgeons so perhaps has some inside scoop he hasn't shared with me.

 

I'm long overdue for an update on this, but did want to let observers of the SPI 1005 thread know that after I posted this I received a follow-up by my contact for the study. Someone in charge of the study checked further and concluded that I would be a candidate to participate if I met all the other criteria. I was evaluated and did qualify. So, I took the medication (or placebo) for the first month and believe I may have possibly had SPI 1005 as I could see an improvement in my tinnitus (it had become more pulsatile just prior to starting the medication and was much quieter when I took the 'medication') and the follow up audio testing showed I had a 14% increase in my word recognition in noise test. That's not too much of an improvement, and could just be a fluke of my condition at the time, but my words in noise scores were horrific at the start so I'm trying to remain optimistic and I generally did feel a bit better for that month. Of course I don't know if I actually received SPI 1005 and we'll never really know. I'm about 3 weeks out from concluding the first month and, sadly, in the past week I have had some of the worst fullness and actual full-on vertigo that I have ever had since acquiring this beast. I had a bad episode earlier this past week and another one today. I have about 6-7 weeks before I am able to get SPI 1005 for sure. The only things that changed for me were eliminating the trial medication and I did switch from Famciclovir to Valacyclovir (which the drug trial doctors said was okay to do). I switched because I've been on Famciclovir at full dose for about 6 months and my integrative medicine doctor thought it might be a good idea to switch, but left it up to me. I'm going to switch back to Famciclovir just to see if I notice any improvement because, as so many of you well know, these vertigo/nausea/etc. episodes are NOT fun. I know the antiviral part doesn't really fit with this thread, but if anyone has thoughts/experiences about any related experiences to their use with antivirals I'd love to hear from you. Still taking all my other supplements and JOH protocol as well. Everyone take care.

 

@Kurtin - That's great news that those in charge of the study reconsidered & allowed you to participate! The tough part of a drug trial is "the not knowing" - placebo or real medication?!? I have to believe that even w/ the placebo some people get at least temporary improvement due to the "placebo effect"

I'm really sorry that after some improvement, you've lost ground though. I haven't tried antivirals yet but have recently tested w/ an excessively high immune response to EBV (even though I'm feeling fine) so will ask my functional med doctor about taking an antiviral to see if it knocks that down & helps w/ my MD symptoms.