Have anyone of u use SEMAX for stroke?

[bolt usmle]

Hi,have anyone of u ever heard or use this new nootropic agent= SEMAX? is it worthed to try in stroke? I heard many good things about it when dealing with acute stroke...but i cannot find any report or journal about its effectiveness if we start the drug in recovery period for a patient who just had a stroke 6 days ago...please share if u know anything about it...thx

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[typhoonegator]

Semax is a synthetic ACTH analog. It has not been evaluated by the FDA. If you wanted to use it on patients in the U.S. you would need to file an IND with the FDA and design a trial to use it, and get patient consent and ethics approval. You can't just order it online from a Russian mail-order pharmacy and start slipping it into patients' breakfasts.

Whenever you "hear lots of good things" and see very little peer-reviewed research on any compound, you should think 2 things:

1) IT'S A GLOBAL CONSPIRACY!!!!!!
or
2) Research should be considered before adopting use

If you believe the first option, call Dateline and I'll wait patiently. If you believe the second option, then if you can figure out why no existing western drug company is exploring this magical compound with potential to be broadly dosed in millions of patients per year, then I would encourage you to explore hypothesis-driven medical research on this hexapeptide in a rigorous and ethical fashion.

 

[neurodoc]

Semax is a synthetic ACTH analog. It has not been evaluated by the FDA. If you wanted to use it on patients in the U.S. you would need to file an IND with the FDA and design a trial to use it, and get patient consent and ethics approval. You can't just order it online from a Russian mail-order pharmacy and start slipping it into patients' breakfasts.

Whenever you "hear lots of good things" and see very little peer-reviewed research on any compound, you should think 2 things:

1) IT'S A GLOBAL CONSPIRACY!!!!!!
or
2) Research should be considered before adopting use

If you believe the first option, call Dateline and I'll wait patiently. If you believe the second option, then if you can figure out why no existing western drug company is exploring this magical compound with potential to be broadly dosed in millions of patients per year, then I would encourage you to explore hypothesis-driven medical research on this hexapeptide in a rigorous and ethical fashion.

I share your skepticism about Semax, especially since it is touted as a Panacea for all sorts of ailments (including peptic ulcers...). It is a heptapeptide analog of ACTH, as you said, and is usually administered intranasally. It's really not clear how it is supposed to "work," though its proponents have suggested plausible mechanisms of action.

I have no idea whether or not this stuff is snake oil. It may be useless to treat anything. It hasn't been tested in the US nor approved by the FDA to treat any ailment.

My first concern would be is it potentially harmful? Apparently it is pretty safe, so far as we know. My second concern would be cost. If it's safe and ineffective but expensive, folks could be wasting their money. I've checked online, and it doesn't appear to be outrageously expensive. A third concern would be that some patients might forgo proven treatments for serious conditions (like stroke, AD, etc.) and opt for Semax. Well, that is always a concern for "alternative therapies." But I would ask just how good are the current FDA approved treatments for AD and post-stroke patients?

Of course "research should be considered before adopting use" of this or any other medical treatment...But who's going to pay for the research? Especially if the treatment is some commonly available, cheap, and non-patentable drug? I've been around long enough to remember how long it took us to realize that folic acid supplementation could make a difference in prenatal care and cardiovascular disease, and that Vitamin D deficiency could be a factor in MS and psychiatric disorders.

Speaking of MS, one of the most promising MS treatments is dimethyl fumarate. This has been FDA "approved." Well the fact is that this orally administered drug, which indeed appears to be quite effective for MS, had been approved in Europe for many years as a treatment for psoriasis... It was inexpensive, and indeed you can purchase it at low cost through chemical supply companies (just Google it).

However if you want to prescribe dimethyl fumarate to your US MS patients, they will have to pay about $50k/year for it...

Go figure...

 

[typhoonegator]

Who's going to pay for the research? I don't know. Write a grant. Ask the manufacturer to give you free drug for an investigator-initiated study. Someone has to pay for at least the drug, even if you are willing to do the study on your own time. You can't just start billing people's insurance for an unapproved drug and an data-free indication. Vitamin D and folate have mountains of research devoted to them.

And just because dimethyl fumarate was approved in Europe for psoriasis doesn't mean that getting a new indication and preparation on the label in a new market is a cost-free or risk-free endeavor.

 

[neurodoc]

Who's going to pay for the research? I don't know. Write a grant. Ask the manufacturer to give you free drug for an investigator-initiated study. Someone has to pay for at least the drug, even if you are willing to do the study on your own time. You can't just start billing people's insurance for an unapproved drug and an data-free indication. Vitamin D and folate have mountains of research devoted to them.

And just because dimethyl fumarate was approved in Europe for psoriasis doesn't mean that getting a new indication and preparation on the label in a new market is a cost-free or risk-free endeavor.

Maybe someone will do a study of Semax, but I'm not up to it. I see your points and agree. Vit D, folate (and let's not forget Vit E and aspirin) certainly do have lots of research re their effectiveness in certain diseases, but I'm not sure how much was funded by drug companies. Not much chance of getting an exclusive patent for these agents.

I know that the dimethyl fumarate studies cost a bundle. My gripe is the cost of the drug. And it's not as if the company had to "design" the drug from scratch. Indeed, clues that it could be effective in MS came from experience over many years that it was used to treat psoriasis. The drug that was tested and approved for MS is a slightly different formulation of dimethyl fumarate, but it is essentially the same stuff. Of course since it is slightly different you couldn't use the USP grade DMF you can get for cheap from chemical suppliers, since that wasn't what the FDA approved. If you could, the cost of DMF to treat an MS patient for a year would be around $100, not $50,000.... That was the point I wanted to make.

 

[typhoonegator]

Absolutely true. Price setting for new indications is a dark art. Certainly the drug company wants to make money given the risk they've converted successfully with a positive phase 3 program. There are also considerations of the other drugs marketed for similar indications. If Betaseron costs $20K per year, and you have a new drug that is oral and more effective, it's pretty easy to argue that you should be able to charge more for it. Ultimately, payors have a lot of say in the price point, and they are aware of the relative symbiosis of the situation, even if they are the ones ultimately paying the bulk of the cost.

But I agree that when you step back and see the cost of formulation and the fact that there was a pre-existing indication for an extremely similar drug sold at a lower cost, it's easy to feel a little weird about it. Remember, though, that the relative lucrative environment of drug development in MS is at least partially responsible for the explosion of new compounds to treat RRMS (and soon SPMS). The patients certainly have benefited from this environment. But of course that's not always the case.