Afamelanotide implants and VITILIGO

Afamelanotide

 

There are many theories regarding the causes of Vitiligo and the process through which this disease spreads, however studies have demonstrated that the loss of cutaneous melanocytes can be caused by decreased circulating and lesional skin levels of the naturally occurring melanocortin peptide hormone, alpha-melanocyte (α-MSH).

The Afamelanotide peptide was developed as a synthetic analogue of α-MSH and has been shown to induce skin pigmentation through melanogenesis and thereby subsequently reduce sun (UV) damage to UV exposed skin.

While this peptide’s origins can be traced back to 1991 there haven’t been many breakthroughs regarding the repigmentation properties that are of interest for the treatment of Vitiligo.

 

Afamelanotide is the International Nonproprietary Name for the molecule [Nle4, D-Phe7]α-MSH  initially researched and developed as melanotan-1 and later, CUV1647 by Clinuvel. A subsequent analogue for Melanotan-1 was developed under the name Melanotan II. Products that bear the name Melanotan II are currently sold as self-tanning injectable supplements on the internet but are not FDA approved. There is also a large community (melanotan.org) of Melanotan II users that have documented the results obtained while using Melanotan II subcutaneous injections or nasal spray for self-tanning purposes.

On the 5th of september 2007 The U.S. Food and Drug Administration (FDA) has issued a Warning Letter for the illegal sale and marketing of the product Melanotan II. „FDA recommends that consumers who are currently using Melanotan II stop using this product and consult their health care provider if they have experienced any adverse events that they suspect are related to its use.”

 

The Australian company, Clinuvel that first announced clinical trials for vitiligo repigmentation has since then published the trial results at the end of 2012.

Regarding the commencement of its INSPIRE (International SCENESSE® Pilot Repigmentation Evaluation) program to evaluate the use of its first-in-class drug SCENESSE® (afamelanotide) as a repigmentation therapy in vitiligo, Dr Mark Lebwohl, Professor and Chair of Dermatology at Mount Sinai Hospital in New York and an investigator on the Clinuvel study, said: “I think this is an exciting, major advancement for vitiligo, a disease for which we do not have adequate effective treatments,”. “We were thrilled with the speed at which the pigment returned.”

The method Clinuvel uses to administer the afamelanotide peptide is by subcutaneous implant. This method of administering the peptide, combined with narrowband UV-B (NB-UV-B) phototherapy has been shown to induce faster and deeper repigmentation. To quote from the article: „All patients experienced follicular and confluent areas of repigmentation within 2 days to 4 weeks after the initial implant, which progressed significantly throughout treatment. All patients experienced diffuse hyperpigmentation.”

 

Afamelanotide

In case you were wondering what an afamelanotide implant is and the implications of this procedure we have gathered some information provided by the recepients of such implants.

The implant is about 10mm by maybe 3mm, white and sort of waxy looking. The recipient is given an injection of anaesthetic in the right lower abdomen, an incision is made and the implant is inserted below the skin with a pair of forceps and then the area is stitched up. There may be a visible scar that fades away with time and the implant can be felt under the skin until it is completely absorbed.

While this treatment is not available yet, Clinuvel is undergoing all legal steps to introduce it in the near future as a treatment for a number of conditions such as Porphyria, Vitiligo, Photodermatoses &Skin Cancer prevention.

 

PHOTO SOURCE: http://www.technologyreview.in/biomedicine/24960/

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Comments

Submitted by Uhoroyco on

Another example of lazy journalism. the following statement is incorrect. "Afamelanotide can be found in retail under the names Melanotan and Melanotan II and is advertised as a product that provides a natural tan without the need for sun. There is also a large community (melanotan.org) of Melanotan users that have documented the results obtained while using Melanotan subcutaneous injections or nasal spray for self tanning purposes."
Afamelanotide is ONLY available in trials and in Italy and Switzerland for patients with EPP. The injections people use are unlicensed, non regulated and illegal in most countries. They are not afamelanotide. Use at you own risk

Submitted by GeorgeD on

Thank you for your comments. While the article doesn't state that the use of melanotan is considered somewhat illegal I kindly suggest taking a look here http://en.wikipedia.org/wiki/Afamelanotide before calling other people lazy. Also, while writing the article we had to keep it short so as the reader can mantain interrest. That of course is one of the basics of journalism and also the external links provide a more in depth perspective.

Submitted by joeschiltzopoodaddy on

Did you even read that link ? It just confirms what I had said! you are now proven lazy. Melanotan from the internet is NOT afamelanotide. There is a public health concern here and you should be ashamed.

Direct quote from Wikipedia "The molecule [Nle4, D-Phe7]α-MSH has yet to be approved for use by additional governmental drug regulatory bodies outside of trials, but unlicensed and untested powders sold as "melanotan" are found on the Internet[8] and are reported to be used by tens of thousands of members of the general public.
Multiple regulatory bodies have warned consumers the peptides may be unsafe and ineffective in usage, with one regulatory agency warning that consumers who purchase any product labeled "melanotan" risk buying a counterfeit drug.[9] Clinuvel Pharmaceuticals, the company developing afamelanotide, and medical researchers have warned consumers that counterfeit products sold using the names "melanotan I and II", could "pose a hazard to public health".[10] Clinuvel has stated publicly that products sold online as "melanotan" are not afamelanotide.[11]

Submitted by GeorgeD on

Well the article was not meant to encourage any kind of usage of said product but just to inform. I agree that the contents of the injectable self tanning product are of questionable quality and that there aren't a lot of people with vitiligo experimenting with it. The article was just meant to inform about what may be available in the near future. I apologize if you felt encouraged to use it in any way and also would advise you research for yourself before complaining. You might find out that these products are sold by a lab in Australia and that backwards engineering the molecule is not so hard to achieve. Nevertheless you should direct such comments in a more productive area, such as the forum board of melanotan.org. Again, the article is not about Melanotan so treat that as a side note. My main focus was the research done by Clinuvel and the implications of an Afamelanotide implant.

Submitted by ad10fernitsouthern on

You are still not getting it. Don't worry about me, I am confident that I know a lot more about this than you do and I certainly have no intention of using a non regulated product.

My issue is with your statement that Afamalenotide is available as Melanotan I or II. You need to acknowledge that this is incorrect and misleading.

Submitted by Mircea on

The original article has been modified in two aspects:

1) a clear relation between afamalenotide and melanotan 1&2

2) mentions of the health warning issued by the FDA

Submitted by Bob on

Stop worrying so much about other people's health. The products obtained from the internet by and large ARE Afamelanotide. Simply because a product hasnt received the government's seal of approval doesnt mean it is some deadly cocktail or is ineffective and unsafe, it simply means you use it at your own risk. God, when did we become a world full of infants who need your protection? I have bee taking melanotan 2 pretty consistently for over ten years with no ill effect that I am aware of. Tens of thousands of others have been doing the same. And guess what? there has been exactly zero deaths or injury attributed to the drug. Even if there were deaths or injury, they would probably be attributable to the government pushing usage underground, resulting in people using unsafe practices. The fact of the matter is, that do-gooder busybodies like you end up harming and killing people more than if you minded your own business and let people live their lives.

Submitted by BONITA on

WELL I WANT TO THANK YOU FOR THE INFO I HAVE A 3 AND HALF YEAR OLD THAT WE WAS JUST TOLD HAS VITILIGO AND I NEED ALL THE INFO I CAN GET TO HELP MY SON. SO THANK YOU

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