Follow up: Info Regarding Pharmaceutica... - My MSAA Community

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Follow up: Info Regarding Pharmaceutical Grade/Compounded Biotin

suzy20
suzy20

Hi everyone,

I wanted to follow up regarding the Pharmaceutical Grade/Compounded Biotin question. I discussed it with my neuro immunologist today at my appointment. See below for a link with information about the study.

My Dr. said that the study was done on patients with progessive forms of MS, and that the results were promising. Because there are so many DMT's for R&RMS, much of the reserarch now is being conducted for the more progressive forms of the disease. However, they are optimistic that it could help those with R&RMS.

Attached is a photo of the Biotin I will be taking. It is approximately $50/month. The dose is 100 mg three times per day. My doctor said that It is a typle of B vitamin which won't suppress the immune system and that It is non-toxic with no known side effects. See healthline link for more details.

*NOTE: This is a compounded pharmaceutical formula, not one you can purchase over the counter.

**Check with your doctor to see what they say. I just ordered it so I cannot report any results yet, but I will in down the road . At this point, I’m just sharing information.

healthline.com/health-news/...

27 Replies
oldestnewest

suzy20 Fantastic! Thanks for sharing! :)

greaterexp
greaterexpCommunityAmbassador

Thank you for the information. Please tell us how you get along.

suzy20

I was trying to figure out why the Phase 3 trial in the 2015 article you referenced wasn't enough to support a marketing application for this high-dose Biotin. It looks like the sample size was small (144) and was limited to one geographical location (France). The study was also on Spinal Progressive MS, a subset of PMS.

One excerpt from the article that explains the interest in Biotin is: "According to the study, one hypothesis to explain the cause of progressive MS is a phenomenon called “virtual hypoxia.” The phenomenon is caused by a mismatch between increased energy demand by the damaged nerves, and decreased energy production because of damage to the mitochondria. The mitochondria’s job is to manufacture fuel for the nerve cells to function properly. Biotin helps to make this happen."

I checked for ongoing trials of Biotin and there is one Phase 3 trial that is actively recruiting patients with PPMS or SPMS in the US, Canada, and the EU. They are aiming to recruit 600 participants globally. (The study began in 2016 and it is unclear how many patients are already enrolled.) The study title is: "Effect of MD1003 in Progressive Multiple Sclerosis." It can be viewed at clinical trials.gov by doing a search for "MD1003" and "MS." (The ClinicalTrials.gov identifier is NCT02936037.)

Or plug: clinicaltrials.gov/ct2/show... into your browser.

If you're interested in participating, scroll toward the bottom where it says "Contacts and Locations" and click on "Show 67 Study Locations" to see if there is a location near you.

Patients won't know if they are on Biotin or a placebo for approx. 15 + months, so that is a downside to consider. (I don't see where it is a 1:1 ratio or a 2:1 ratio, so I'm unsure what the odds are of getting Biotin versus placebo.) After this time (~ 15 mos.), all participants will be on Biotin for the next 12 months. Study drug is provided.

There is also a dedicated study website: spi2study.com but I recommend checking out the inclusion/exclusion criteria and other study details first on clintrials.gov, before going to the study website.

Of course, if you can afford it, it might be better to just pay $50 a month to get the high-dose Biotin for yourself, upfront, as Suzy has.

Food for thought. :)

suzy20
suzy20 in reply to Nom_De_Plume

Excellent points, much appreciated!

erash
erash in reply to Nom_De_Plume

Nom_De_Plume and suzy20

I believe the SPMS study mentioned is the one I referred to with the higher levels of disability edss required for participation

Thanks for the specifics @nom_de_plume

Nom_De_Plume
Nom_De_Plume in reply to erash

erash

Well, I'm glad that your EDSS is on the lower end of the scale!! :)

Interesting that they chose progressive forms of MS for the study. I guess they needed to to show improvement. It seems likely a risky design though since many are on a downward trajectory already. Harder to show improvement, I would think.

Anyway, thanks for your input about drug interactions, thyroid labs, etc.

It'll be interesting to see how the data turns out. Won't be getting a read out for at least another year and a half, probably more like 2 years +. Too bad there isn't a standardized test for energy levels, huh?

erash
erash in reply to Nom_De_Plume

Me too Nom_De_Plume

Glad I don't qualify based on a high edss

Good point about measuring improvement in a disease state that naturally progresses. I guess they'll measure against a control group but given the individual nature of ms, the effect size needed would have to be enormous?

Standardized energy measures...VO2 max? An accelerometer?

I swear I use more energy to do the same amount of work now that I have MS and lots of rest breaks b/w expenditure 😴

Those dysfunctional mitochondria 🙁

So sorry...I'm rambling 😜

CalfeeChick
CalfeeChickCommunityAmbassador in reply to Nom_De_Plume

Bummed out! I would so love to participate in the trial, I just turned 69 in May. But if you take into consideration I was a very athletic person right up to win MS slammed into me, I'm still healthier than most people before age 65. So I don't qualify because of the age factor 😔 ☹️🙃 !!!

@Calfeechick

That IS a bummer! :(

At least we all know the dose they're studying and it appears to be available through compounding pharmacies with a script, as Suzy explained. (One has to be cautious with compounding pharmacies, but that's another story.)

suzy20
suzy20 in reply to Nom_De_Plume

CalfeeChick and Nom_De_Plume -- Just to clarify, you do not need a script. You can just go to the website and order it directly. But, of course, check with your doctor first:) I agree, be careful about compounding pharmacies. The photo I provided of the pharmacy from whilch I ordered was provided by a healthcare person at Stanford Neuroscience Center where I receive care.

CalfeeChick
CalfeeChickCommunityAmbassador in reply to suzy20

Hey, suzy20, I go to the UCSF MS Clinic right up the road from Stanford! We drive over there from Lodi, near Sacramento.

suzy20
suzy20 in reply to CalfeeChick

CalfeeChick I know that drive! Let me know next time you are here, maybe we can grab a cup of coffee...

erash
erash in reply to suzy20

suzy20 and CalfeeChick

I want to join you for that ☕️

Wish I wasn't several 1000 miles away...🛩

suzy20
suzy20 in reply to erash

erash That would be fun!

CalfeeChick
CalfeeChickCommunityAmbassador in reply to suzy20

I'll let you know 🤔 sometimes I have a little time when he has VA appt.

Linda3579
Linda3579 in reply to suzy20

Hi Suzy,

I go to Stanford too. I hope you are doing ok.

Linda

Nom_De_Plume
Nom_De_Plume in reply to suzy20

@suzy20 Thanks for clarifying about not needing a script and about the source of your compounding pharmacy referral!

I was at Stanford a long time ago (pre-MS dx). It is beautiful there! 😊

erash
erash in reply to CalfeeChick

CalfeeChick

That reminds me of a thought I had the other day...I'm more able than many without a diagnosis of disability

All those yrs of education and exercise hopefully pay off!

suzy20 please let us know how you do with it.

People I've talked with that have tried had no appreciable side effects but after a few yrs noticed no difference

There's a study, I believe outof UCSF (San Francisco) enrolling RRMS/SPMS but the EDSS (more disability) required was too high for me to enroll (you could participate remotely).

Do be careful. Biotin can interact with some meds and will alter thyroid lab results (not your thyroid, just the lab)

Good luck!

suzy20
suzy20 in reply to erash

erash Thank you so much I will keep you posted!

Great Job describing the Biotin issue. For others seeing this, the 100mg is 100,000mcg, so what some of you are seeing on the shelves are in mcg's, very small doses. Same brand I switched to after the first at a lower cost than the first. No, I have not noticed a change, but changes come slowly with nutrition. But, they do!!! Hope this helps.

MarkUpnorth I echo your important point about the dosage. The bottles of Biotin at GNC and other retail places have a dosage that is a fraction of the Biotin being used in the study.

suzy20 I have been taking high dose Biotin for about a year (I have SPMS) and after it kicked in, which took a few weeks I saw a definite benefit in strength, endurance and increased walking distance. After a couple of months the benefit seemed to diminish; possibly I've developed a tolerance or this might be because of an increase in disease activity which has occurred. (Since I don't have relapsing MS I don't call this a relapse, I call it a drop off. part of the pattern of the disease for me)

In any case I recommend high dose Biotin and I recently found the same product on Amazon that I had been purchasing from a compounding pharmacy for considerably more $. See link. But it seems I am not the only one to make this discovery, they are selling out fast -

amazon.com/gp/product/B01FR...

@BillD999 and @suzy20

I want to be sure I am reading this correctly: The Amazon price is lower than that of the compounding pharmacy?

Any idea if they are of comparable quality? (Just wondering if anyone has looked into that already.)

Thank you!

Yes the Amazon price is considerably lower than I was paying at the pharmacy for the identical product.

@Nom_De_Plum

Good question.... I don't know!

I used to give my horse biotin to increase the growth of good hard hooves. Has anyone who is using this product noticed stronger hair and/or fingernails? I am definitely going to ask my dr. about it.

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