Last week, I was in the MSWorld chatroom and the topic of Biotin came up. A number of chatters had not heard of Biotin, but were interested in learning more. This post is designed to summarize what I know about Biotin and answer some of the more frequently asked questions. I have not been involved in the Biotin trials, have no relationship with any of the trial participants, companies and claim no medical (or any other) expertise.
Is the drug approved?
No, high-dose Biotin is NOT approved and may not be approved until 2017. There are risks taking any chemical up to and including death. You should consult your neurologist PRIOR to starting any medication, supplement, treatment of therapy.
What is Biotin?
Biotin is water-soluble member of the B-complex group of vitamins. Biotin is also known as Vitamin B7 or Vitamin H or coenzyme R or MD1003. MD1003 may potentially lead to a therapy for progressive forms of Multiple Sclerosis to improve disability and slow progression.
Biotin is an important component of enzymes in the body that break down proteins, fats and carbohydrates for energy use. Biotin is necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids. Biotin assists in various metabolic reactions involving the transfer of carbon dioxide.
Biotin is a co-enzyme for several carboxylases, one of which is thought to have a key role in myelin synthesis. Thus, it could potentially alleviate MS symptoms in two ways: by increasing ATP levels and reversing the “virtual hypoxia” found in MS muscles; and by promoting myelin repair via fatty acid synthesis.
High-Dose Biotin Hoopla
So what's the hoopla about? At the 2015 American Academy of Neurology meeting, the Phase III positive results of High Doses of Biotin were presented by Ayman Tourbah, MD, PhD. In the trials, patients with progressive multiple sclerosis (MS) showed improvements during treatment with a high dose of biotin (MD1003). The Clinical Trials notices can be found here: https://clinicaltrials.gov/ct2/resul...&Search=Search
What were the trial results?
What about side effects? MD1003 was well tolerated. The overall incidence of adverse events was similar across the two groups.
Is Biotin safe for pregnant women and unborn children?
There is no guarantee that high-dose Biotin is safe for anyone. The FDA has not approved the medication and it may well be teratogenic. Women pregnant or considering becoming pregnant should always consult with a physician prior to starting any medication or supplement.
How does the drug work?
Overall, high doses of Biotin, could target the main metabolic processes related to progressive MS by:
Sources of Biotin
Biotin is natural substance normally consumed as part of your nutritional diet. Biotin deficiency is rare because, in general, intestinal bacteria produce biotin in excess of the body's daily requirements. Foods with high levels of biotin include: peanuts, almonds, sweet potato, eggs, onions, oats, tomatoes, carrots, walnuts and salmon, soybeans, mushrooms, and pumpkin and sunflower seeds. In Western societies the daily Biotin intake range is estimated between 35-70 micrograms (mcg).
Biotin is currently available as an over-the-counter supplement sometimes used for diabetics, skin, brittle nails, hair health and a number of other conditions. Current supplements are limited to 10,000 mcg or 10 mg. The current supplements have fillers often in excess of the Biotin amount. If you are taking 30 pills/day you are getting a significant amount of fillers. Note: significant care needs to be taken while sourcing Biotin. Many sources are approved for veterinary uses, but not deemed safe for human consumption.
Is Biotin new? Who makes Biotin?
Biotin is naturally occurring and certainly not new. The ultra-high dose in the trial is many, many times over the recommended daily intake is new. Because of the high dose pharmaceutical grade Biotin is required for purity.
MedDay, a biotechnology company and DSM Nutritional Products have entered into a partnership to manufacture of pharmaceutical grade D-Biotin.
What dose was tested?
MedDay trials tested between 100-600 mg doses. The final Phase 3 trial dose was 300 mg administered in 100 mg does three times/day (100 mg TID).
If the drug is not approved how are people already taking it?
Since Biotin is available OTC, some MS patients have taken it upon themselves to start taking it. Biotin is also available in bulk powder form and patients are individually measuring their doses. Compounding pharmacies can also make Biotin available in higher doses, but require a prescription. Patients should be cautious before starting any supplementation as contents are not regulated like FDA-approved medications.
What will Biotin cost?
There's no telling what the final market price for high-dose Biotin would be. You can currently take 300 mg of over-the-counter Biotin for about $2.50/day. I would imagine that MedDay will price high-dose Biotin to maximize profits. One problem for Med Day is compounding pharmacies will easily be able to reproduce 100mg doses of high-grade Biotin for a few dollars/day.
There is also no way to know what, if any, copay assistance programs may be available.
Sources
Effect of MD1003 (High Doses of Biotin) in Progressive Multiple Sclerosis
http://sullivanweb.me/webinars/MedDa...28%201443.flv/
High doses of biotin in chronic progressive multiple sclerosis: A pilot study http://www.msard-journal.com/article...006-1/fulltext
Cerebrospinal fluid levels of biotin in various neurological disorders. - PubMed
http://www.ncbi.nlm.nih.gov/pubmed/10577274
Biotin benefits ‘clinically relevant’ in progressive multiple sclerosis
http://www.medwirenews.com/44/106327...sclerosis.html
Barts MS Blog
http://multiple-sclerosis-research.b...n-results.html
http://multiple-sclerosis-research.b...otin-time.html
http://multiple-sclerosis-research.b...tin-story.html
Biotin
http://www.webmd.com/vitamins-and-su...t-guide-biotin
High Doses of Biotin Improve Symptoms of Progressive MS
http://www.healthline.com/health-new...sive-ms-052215
Is the drug approved?
No, high-dose Biotin is NOT approved and may not be approved until 2017. There are risks taking any chemical up to and including death. You should consult your neurologist PRIOR to starting any medication, supplement, treatment of therapy.
What is Biotin?
Biotin is water-soluble member of the B-complex group of vitamins. Biotin is also known as Vitamin B7 or Vitamin H or coenzyme R or MD1003. MD1003 may potentially lead to a therapy for progressive forms of Multiple Sclerosis to improve disability and slow progression.
Biotin is an important component of enzymes in the body that break down proteins, fats and carbohydrates for energy use. Biotin is necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids. Biotin assists in various metabolic reactions involving the transfer of carbon dioxide.
Biotin is a co-enzyme for several carboxylases, one of which is thought to have a key role in myelin synthesis. Thus, it could potentially alleviate MS symptoms in two ways: by increasing ATP levels and reversing the “virtual hypoxia” found in MS muscles; and by promoting myelin repair via fatty acid synthesis.
High-Dose Biotin Hoopla
So what's the hoopla about? At the 2015 American Academy of Neurology meeting, the Phase III positive results of High Doses of Biotin were presented by Ayman Tourbah, MD, PhD. In the trials, patients with progressive multiple sclerosis (MS) showed improvements during treatment with a high dose of biotin (MD1003). The Clinical Trials notices can be found here: https://clinicaltrials.gov/ct2/resul...&Search=Search
What were the trial results?
- After 12 months of treatment, the average clinical global impression score was 4.05 in the biotin group versus 4.62 in the placebo group, and the corresponding subject global impression scores were 4.27 versus 4.76, with both differences being statistically significant.
- The primary endpoint was either improvement on the Expanded Disability Status Scale (EDSS), defined as a 1-point improvement for patients with a baseline score of 4.5 to 5.5 or of 0.5 points for patients with a score of 6 or 7, or at least a 20% improvement on the timed 25-metre walk (TW25).
- The proportion with this outcome at 9 months, and confirmed at 12 months, was 12.62% in the 103 patients in the biotin group versus 0.0% of the 51 in the placebo group. More patients met the primary endpoint with the EDSS than the TW25, Tourbah noted.
- Patients taking biotin improved on the EDSS by 3 months and remained improved for the duration of the study, whereas the placebo group had worse scores than at baseline except for a slight improvement at month 3, which Tourbah attributed to the placebo effect.
- The relapse rate was 3.9% in the biotin group, compared with 7.8% among patients taking placebo. However, among patients who underwent magnetic resonance imaging, rates of new and enlarging T2 lesions were higher in the biotin group than the placebo group (23.4 vs 13.0% and 8.5 vs 0.0%, respectively), although this was not significant.
What about side effects? MD1003 was well tolerated. The overall incidence of adverse events was similar across the two groups.
- Adverse effects were similar in the two groups. Five patients in the biotin group had apparent hypothyroidism by the end of the study, but Tourbah said this was a consequence of high plasma biotin levels interfering with immunoassays, producing misleading test results.
- High-dose Biotin is potentially teratogenic - ie could be harmful to an unborn embryo/fetus, so it should not be taken by any women planning on having children or pregnant.
- High-dose Biotin interferes with over 100 types of lab tests that use biotinylated assays/antigens. In the trial this resulted in five patients showing up as being hyperthyroid even though they weren't (and thyroid levels weren't one of the tests being given to all trial participants, which means more may have had false indications if they'd have been tested).
- One trial subject went as far as having their thyroid removed, even though it turned out later the lab test was false. Other examples of readings that are messed up are some to detect cancer, to detect pregnancy, heart infact diagnosis, hormones.
Is Biotin safe for pregnant women and unborn children?
There is no guarantee that high-dose Biotin is safe for anyone. The FDA has not approved the medication and it may well be teratogenic. Women pregnant or considering becoming pregnant should always consult with a physician prior to starting any medication or supplement.
How does the drug work?
Overall, high doses of Biotin, could target the main metabolic processes related to progressive MS by:
- activating the Krebs cycle in demyelinated axons to increase energy production;
- activating the Krebs cycle in oligodendrocytes to increase the production of citrate required for lipids synthesis and;
- activating ACC1 and ACC2, the rate-limiting enzymes in the synthesis of long chain fatty acids required for myelin synthesis
Sources of Biotin
Biotin is natural substance normally consumed as part of your nutritional diet. Biotin deficiency is rare because, in general, intestinal bacteria produce biotin in excess of the body's daily requirements. Foods with high levels of biotin include: peanuts, almonds, sweet potato, eggs, onions, oats, tomatoes, carrots, walnuts and salmon, soybeans, mushrooms, and pumpkin and sunflower seeds. In Western societies the daily Biotin intake range is estimated between 35-70 micrograms (mcg).
Biotin is currently available as an over-the-counter supplement sometimes used for diabetics, skin, brittle nails, hair health and a number of other conditions. Current supplements are limited to 10,000 mcg or 10 mg. The current supplements have fillers often in excess of the Biotin amount. If you are taking 30 pills/day you are getting a significant amount of fillers. Note: significant care needs to be taken while sourcing Biotin. Many sources are approved for veterinary uses, but not deemed safe for human consumption.
Is Biotin new? Who makes Biotin?
Biotin is naturally occurring and certainly not new. The ultra-high dose in the trial is many, many times over the recommended daily intake is new. Because of the high dose pharmaceutical grade Biotin is required for purity.
MedDay, a biotechnology company and DSM Nutritional Products have entered into a partnership to manufacture of pharmaceutical grade D-Biotin.
What dose was tested?
MedDay trials tested between 100-600 mg doses. The final Phase 3 trial dose was 300 mg administered in 100 mg does three times/day (100 mg TID).
If the drug is not approved how are people already taking it?
Since Biotin is available OTC, some MS patients have taken it upon themselves to start taking it. Biotin is also available in bulk powder form and patients are individually measuring their doses. Compounding pharmacies can also make Biotin available in higher doses, but require a prescription. Patients should be cautious before starting any supplementation as contents are not regulated like FDA-approved medications.
What will Biotin cost?
There's no telling what the final market price for high-dose Biotin would be. You can currently take 300 mg of over-the-counter Biotin for about $2.50/day. I would imagine that MedDay will price high-dose Biotin to maximize profits. One problem for Med Day is compounding pharmacies will easily be able to reproduce 100mg doses of high-grade Biotin for a few dollars/day.
There is also no way to know what, if any, copay assistance programs may be available.
Sources
Effect of MD1003 (High Doses of Biotin) in Progressive Multiple Sclerosis
http://sullivanweb.me/webinars/MedDa...28%201443.flv/
High doses of biotin in chronic progressive multiple sclerosis: A pilot study http://www.msard-journal.com/article...006-1/fulltext
Cerebrospinal fluid levels of biotin in various neurological disorders. - PubMed
http://www.ncbi.nlm.nih.gov/pubmed/10577274
Biotin benefits ‘clinically relevant’ in progressive multiple sclerosis
http://www.medwirenews.com/44/106327...sclerosis.html
Barts MS Blog
http://multiple-sclerosis-research.b...n-results.html
http://multiple-sclerosis-research.b...otin-time.html
http://multiple-sclerosis-research.b...tin-story.html
Biotin
http://www.webmd.com/vitamins-and-su...t-guide-biotin
High Doses of Biotin Improve Symptoms of Progressive MS
http://www.healthline.com/health-new...sive-ms-052215
informative! Appreciate you sharing! 
fed
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