What if you could get all the benefits of metformin, but without the abdominal pain, diarrhea, gas, and vomiting that this medicine often brings? Well, such a treatment exists, and it works. Why hasn’t it come to market?
A group of enterprising osteopaths and pharmacists at Scarbrough Pharmaceutical Innovations, LLC, in Akron, Ohio, have patented a transdermal metformin (TDM) formula, or metformin that absorbs through the skin. The prescribed dose is squeezed out of a syringe and rubbed into the skin, although it could also be made into a skin patch. One of these osteopathic doctors, Jay Shubrook, DO, has been good enough to explain the issues to me.
TDM has the same benefits as oral metformin. It lowers insulin resistance, prevents dumping of glucose by the liver, encourages weight loss, and treats polycystic ovary syndrome (PCOS).
This could benefit millions of people. Whenever I or others write about metformin on this site, we get dozens of comments, equally divided between “This drug is wonderful,” and “This drug is awful. It tore up my stomach.” Many people can’t take it, or it makes their lives miserable.
The Ohio researchers prepared and tested a mix of four different “polymers,” or gels that can deliver metformin through the skin into the blood. According to their patent application,
One advantage of using transdermal metformin is its ability to bypass the gastrointestinal system. This allows the drug to not have the gastrointestinal side-effects associated with oral metformin.
Another unexpected benefit is that metformin seems to be absorbed through the skin much more effectively than through the digestive system. Apparently, 50% to 90% of oral metformin is degraded in the intestines and brings no benefit. According to research, a person taking 1500 milligrams (mg) per day of oral metformin can probably get the same benefit with a daily dose of 100 mg of TDM, delivered in two separate doses of 50 mg each.
So why isn’t this drug available? TDM’s inventors are “compounding pharmacists.” Food and Drug Administration (FDA) rules for compounding pharmacies forbid them from acting as manufacturers. They are only allowed to create compounds suited to an individual person’s needs, according to specific doctor’s order. They can’t make a product that any pharmacy can stock and provide.
Compounding pharmacists are extremely valuable. They can make drugs that corporate pharmaceutical companies don’t find profitable enough to make.
But these rules can cause strange situations. I used to take a multiple sclerosis drug called 4-AP that helped me walk better. It wasn’t FDA approved, but a compounding pharmacist could make it up with a doctor’s order, for about $12 a month.
Thousands of people benefited. Most doctors wouldn’t prescribe it, though. As with TDM, they hadn’t even heard of it. Finally, a drug company got involved and did the extensive safety and effectiveness research for drug approval. It’s now called Fampridine. Any neurologist will prescribe it, but it costs about $400 a month, so many people can no longer afford it!
The Ohio osteopaths have a patent on their TDM formula, but it’s not FDA approved. According to the FDA, “Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.” Since there is no brand name TDM, it may be that some drug company will have to undertake the safety and efficacy research any new drug must go through. If that happens, TDM might become available, but only a long time from now, and at a very high cost.
Why should any of that be necessary, when we already know metformin is safe and effective? We’re just changing the route to protect our stomachs.
Most doctors know nothing about TDM, and many will be rightly concerned about not understanding the lower doses needed. Some will not take the time and effort to consult with a compounding pharmacist. But if you’re a person who hasn’t tolerated oral metformin, you might be able to find a doctor who will order TDM for you, and a pharmacist who will compound it. Unfortunately, since it’s not FDA approved, it probably won’t be covered by insurance. People I have talked to are paying about $60 a month for two doses a day.
At this point, no drug company is likely to take on the expense and effort to get TDM approved. The profit margins aren’t high enough. The Ohio pharmacists are working on it; so might be a company in India, but with their lack of resources, it will take many years to get approval, if they ever do.
I think it’s up to us to demand that FDA fast-track TDM. We should write to the American Diabetes Association, the FDA, the PCOS Foundation, the American Association of Clinical Endocrinologists, and everyone else we can think of, demanding that resources be put into this drug, which we already know works and which could save millions from misery.
If you want TDM now, find a compounding pharmacy that will make it up for you, like Scarbrough Pharmacy in Ohio (the inventors.) Or someone closer to home. Then talk to your doctor about ordering it.
If desired, the pharmacist will work with your doctor. Dr. Shubrook says “We look at the clinical glucose response. We order a comprehensive metabolic profile as well but have never seen problems with this.”
Roughly 100 to 200 mg a day in divided doses might be a good place to start, but ask your doctor about that, after showing him some of the papers linked in this article.