Any news about SPI 1005?

yes may be worth a try, thanks

 

I was never told to take it with or without food, they said it didn't matter. I tend to have an iron gut, not much bothers my stomach, which is the reason they most often recommend taking drugs with food. That and the fact that sometimes drugs are metabolized differently, food vs no food. Either way I take it at 9 and 9, regardless of whether I've had food or not.

 

It's interesting. When I did the 30-day trial, they said it didn't matter if I took it with food or not. When I got the real drugs, they specifically said to take it two hours before eating.

 

Maybe I'll ask my study contact and see what she says. Absorption would definitely be different with food, but whether it makes a difference, I guess we don't know. If I have to compromise I'll try to take it as far before eating as possible.

 

I am starting Day 9 today. Thursday morning, I woke up dizzy. Not full vertigo. I just had some dizziness when moving my head from left to right or up and down. I think it's getting better, albeit slowly. Side to side isn't as bad this AM, but still bad up and down. I'm stumbling around the house like a drunkard. No nausea, thankfully.

So now I'm wondering if it's the drug causing it. I've been symptom-free for almost nine months on the JOH regimen. And now, suddenly, I'm getting dizzy after starting this new drug.

 

sorry to hear this hope it's a coincidence

 

Thank you all for the kind words concerning the loss of my pups.
I had to chime in here on the timing of the drug in regards to food. When I was doing the placebo/real drug on first month they were adamant about no food 2 hours prior. 30 minutes to an hour after taking fine. Even gave me paperwork stating this. Fast forward to the first month on the real drug. I forgot about the 2 hour window before taking. On the 10th day, I remembered and called the tech I deal with. He said it was important to take on empty stomach as it helps with absorption. So.... I have been taking with no food 2-3 hours after last bite to eat. I wait approximately 40 minutes before eating anything. I do my workout, Bible study, etc. then eat. Bazookaman:
I was having crazy dizzy attacks prior to the drug. I can honestly say it has improved. Not 100%, but better each day. Had a dizzy spell last night that was as you described. Neck in slow motion, walking like a drunkard, etc. Popped a chewable 12.5 mg meclizine and good as new in 30 minutes.
For me, I do not think it is the drug causing it, as mine was a whole lot worse prior to the drug. Coincidence? We shall see...
Also, while talking to the tech, he told me it takes awhile for the drug to start working. Usually 60-90 days before results. I am praying we all see results at the end of our trial. I am feeling good about it.

 

I figured it would take a while before the drug started doing anything. Maybe it's just an amazing coincidence that after feeling great for nine months, a week after I take a new drug, I get dizzy.

But mine isn't a spell or attack. It's constant. I wake up dizzy, and I go to bed dizzy. Again, nothing horrible. But it's hard to get around and sometimes hard to focus. Plus, being dizzy all the time wears you out, so I'm tired all the time.

 

Argh... that's a tough one for sure! Every waking moment dizzy would be tough. Maybe talk to the folks you see for SPI-1005 and maybe see what they have to say about it. You are In my thoughts and prayers my friend.

 

Very interesting thoughts on taking it without food. On a whim, and based on the thoughts found on this thread I've started to take it 30 minutes prior and two hours after food.

So how am I doing as just completed 19 days on the drug? I can tell you it's the best I've felt in a year since the major onset of my symptoms. Yesterday was my best day in a year, where I almost felt like a normal person. I could count the number of times that I had eustachian tube dysfunction when swallow - probably happened less than a dozen times compared to the usual hundreds. I had minimal hearing distortion. Two days ago I did some heavy labor for 3 hours, wielding a chainsaw and hauling felled trees around. NO ear fullness, NO dizziness. My day job involves sitting in a chair all day, but I enjoy physical work and this was a big test for me.

Bazookaman, on the topic of dizziness, I have had maybe 4-5 times since starting the drug that I felt a bit of dizziness, but it's been different, I didn't feel like I was going to slip into a full blown attack. It could be the drug or something else, but this is the first time I've had those instances without full blown vertigo and I haven't had any of those instances for about 10 month prior until I started SPI-1005.

 

IvanNew, keep in mind that just like this board, when people get relief they often disappear. Human nature is such that we tend to take the time to complain, but don't take the time to celebrate.

 

Does anyone know if or when this drug will be available in the US? I assume it will be by prescription.

Also, are there any warnings about side effects?

 

"Sometime in 2024". I suspect it would be late in the year and, of course, that's if phase 3 trials are successful.

Typical side effects that have been reported in the previous trials were diarrhea, stomach upset. I believe another member of this forum reported stopping the drug due to some side effects as well. So far, I've had zero side effects.

 

Thank you MrE. It seems to be having some success. I have read every post in this thread but I can't remember one fairly important thing. How is it supposed to work? Anti-virals are obvious, Serc has to do with allergies I think, a lot of JOH has to do with blood circulation plus anti-viral.

What is the mode of operation of SPI 1005?

 

I started taking it 1 hour before eating. I would still think it would build up in your system over time,but possibly take longer to have an effect if you ate right away. So far nothing for me except worse tinnitus DAY 88 ON THE DRUG FOR ME.

 

Directly from Sounds Pharma:

"SPI-1005, a proprietary oral formulation of ebselen, is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx is the dominant catalytic antioxidant enzyme in the cochlea and is critical for auditory function."

"Endogenous GPx reduces reactive oxygen and nitrogen species by first binding them to selenocysteine then reducing the selenic acid intermediate through a reduction with glutathione (GSH). SPI-1005 mimics the catalytic activity of GPx1 by utilizing a bound selenonitryl moiety at its active site and cycling with GSH or other thiols. Therefore, ebselen functions catalytically, and is redox sensitive. This efficient mechanism of action allows SPI-1005 to work at low oral doses, unlike antioxidants such as n-acetylcysteine. During the in vivo metabolism of SPI-1005, the selenium moiety is retained and is not bioavailable."

A lot of that is over my head, but I understand that it's a powerful antioxidant and anti-inflammatory. So in the general artillery against Meniere's I look at it as something that helps overall cellular health while reducing inflammation in the inner ear. I think all treatments have their place.

I mentioned it earlier, but my attack is three pronged:
- Antiviral for virus suppression
- LDN for allergies and immune response levelling
- SPI-1005 for cellular health and anti-inflammatory

Of the three I was making tangible improvements with LDN and now SPI-1005. I'm at month 5 of the antiviral and plan to take it for a year.

 

Thank you again, I appreciate it.