A drug that stimulates the body’s tanning response — turning pasty skin caramel for up to two months — has been approved for human trials, but not for tanning.

Although the drug will not be available for cosmetic purposes any time soon, similar compounds are already being widely abused on the pharmaceutical black market. The official product, a man made hormone called afamelanotide, has received U.S. government approval to begin clinical trials.

"It’s a bioabsorbable implant that you just inject into the skin," said Colin Mackie, director of business development for Clinuvel, the company bringing the drug to the U.S. "It stimulates melanin production."

Melanin is the body’s natural pigment. It’s responsible for the color of skin and protects humans from harmful solar radiation. The drug will be tested as a treatment for patients who face serious danger from the sun’s rays, like those with rare genetic diseases or who must take immunosuppressants, Mackie said.

But online retailers already offer a similar (but not identical) compound under a more descriptive brand name, Melanotan II, which American and British health officials warn are already being abused.

"Using it could be dangerous to short and long-term health," British health officials said in November. It has not been tested for safety, quality or effectiveness and we don’t know the potential side effects yet."

This week two British Medical Journal researchers warned that injecting the compound could change the size and shape of moles, which under normal circumstances can be a precursor to skin cancer.

Melanotan’s plight highlights the difficulty in bringing drugs with large recreational or cosmetic potential to market for decidedly more medical conditions. Before the drugs can make it through safety and efficacy trials, rogue users — almost like pre-release movie filesharers — begin to test the drug on themselves. These high-demand, off-label uses could make regulatory agencies reluctant to approve the pharmaceutical for legitimate uses.

Both Melanotan I and II are synthetic cousins of a naturally occurring hormone that stimulates the production of melanin, the skin’s pigment.

But Melanotan II, in particular, appears to have aphrodisiac and erectile function effects as well.

First created and tested back in the late ’80s at the University of

Arizona, the synthetic tanning hormone received media attention from around the world. Tom

Brokaw, in a 1991 broadcast, said that medical researchers had announced

"what could be the answer" to tanning without the skin damage associated with the process. Wired first featured melanotan back in 2002, dubbing it the "Barbie drug" for its purported ability to induce weight loss and increase libido. The label has stuck and is often used in the press

But the drugs were a good idea in search of a disease. Fair-skinned people’s desire to be tan is not a disease, and the tanning behaviors it induces could cause skin damage and cancer.

Now, though, Clinuvel has found five, admittedly obscure, medical conditions that the drug could treat.





Over the last several years, the Clinuvel’s CEO, Philippe Wolgen, has battled to make his drug sound less and less sexy.

"This will not be a cosmetic drug,” Wolgen told a biotech trade publication last year. “I oppose systemic treatment for cosmetics.”

He changed the company’s name from the provocative Epitan to the boring Clinuvel. It might not make for great advertising copy, but the CEO’s moves appear to have paid off.

"The FDA’s decision is a landmark event in Clinuvel’s growth," Wolgen said in a release this week. "Today’s progress reflects some of the choices we had to make in our program early on in 2006 when changing the direction of the company."

But even as he tries to position his drug to be taken seriously, industry analysts following his company know that the drug could be a blockbusters on the cosmetics market.

After all, once a drug is approved by the FDA for one purpose, it’s easier to extend it to new conditions, just like the glaucoma-treatment turned eyelash enhancer.

"[Melanotan] has potential as a ‘Life Style’ drug for those millions of p eople who prefer just a darker tint," a German analyst wrote back in 2004

[pdf]. "Market research has shown that the product has blockbuster potential in particular when used as a ‘Life Style’ drug, which draws a strong comparison to Botox or Viagra, two products with booming sales today."

Hopeful tanners took it upon themselves to deliver on that blockbuster potential as Melanotan languished in the pharmaceutical industry’s basement.

Recent British media reports indicate widespread use of the compound. Purportedly, the drug is ordered online and comes in a white powder that is mixed with sterile water. That combination is injected into the abdomen.

One woman told the Daily Mail that she intended to keep using the injections despite their unknown provenance and possible side-effects.

"At first, injecting myself in my tummy seemed strange, but now I don’t even think about it — the needle is so fine I hardly feel it," she said. "And I am so pleased with the results that despite the adverse publicity I’m going to continue with them."

An online forum dedicated to Melanotan has more than 50,000 posts, most of which are about "Usage and Experimentation." Many describe detailed regimens for attaining darker skin and/or improved sexual function.

Here in the United States, Melanotan II appears widely available online, although the FDA warned Tennessee’s Melanocorp, which bills its product as "100% US Made Melanotan II," to

stop shipping to Americans in 2007. The company continues to ship to European countries.

The company provides a dozen or so purported before-and-after pictures, like the photo above. Though the results could be suspect, they look eerily similar to results obtained in trials at the

University of Arizona or by Clinuvel (images at left). In early animal trials, injections of the drug caused a yellow dog’s fur to become black and visibly darkened a frog’s skin in minutes.

Image: Top: Melanocorp.com. Bottom: Clinuvel.

See Also:

WiSci 2.0: Alexis Madrigal’s Twitter , Google Reader feed, and project site, Inventing Green: the lost history of American clean tech; Wired Science on Facebook.