The dream of achieving that sun-kissed glow without having to spend time in the tanning bed is undoubtably desired by many. The promise of a pill or injection that could achieve that look would have tremendous public appeal and is probably a billion dollar market.

The drug, Melanotan-1 and Melanotan II, from Melanocorp International in Tennessee works by stimulating the hormone that cause melanocytes to release melanin into the skin and make it turn darker. This is a drug therapy that they have worked on since the late 1980s. Taking the drug appears to reduce the need for excessive sun exposure that may lead to skin cancer and premature aging. And these synthetic cousins of the naturally occurring hormone also appear to have some aphrodisiac and erectile functions as well. But the drug has not found favor with the FDA, presumably because of its large cosmetic and recreational potential, and its manufacturer has never been able or desirous of initiating the regulatory process. The FDA has issued warnings about this drug and has a cease and desist policy for the manufacturer to distribute here in the U.S. The internet, however, has plenty of testimony they sell it overseas (and in Canada) on the so-called pharmaceutical black market.

More recently, Clinuvel Pharmaceuticals from Melbourne Australia has been working on developing the drug afamelanotide. Afamelanotide stimulates the body’s natural ability to produce eumelanin, the dark pigment of the skin which is known to offer photoprotective properties. Afamelanotide, an agonist of the melanocortin 1 receptor (MC1R), is described as an analogue of the naturally occurring hormone, ±-MSH and has a linear configuration as a peptide of thirteen amino acids. Compared to the natural peptide, afamelanotide has a significantly longer half life and an effectiveness that is 10 to 1,000 times greater than one’s natural hormone. The drug has been approved by the FDA for clinical trials as a treatment for patients who face serious danger from the sun’s rays, like those with rare genetic diseases or who must take immunosuppressant medications. In January 2009, afamelanotide was allowed IND status by the Food and Drug Administration (FDA) to commence clinical trials in the USA on humans. Clinuvel intends to begin these trials in early 2009. These trials will focus on its use as a preventative photoprotective agent for five clinical conditions: Polymorphous Light Eruption (PLE) , Actinic Keratosis (AK) and Squamous Cell Carcinoma (SCC), Erythropoietic Protoporphyria (EPP), Solar Urticaria (SU) and Photodynamic Therapy (PDT) It is anticipated that afamelanotide will be administered by medical practitioners and delivered underneath the skin as a subcutaneous injection of a bioabsorbable implant that is approximately the size of a grain of rice.

Clinuvel is obviously aware of the tremendous off-label use of afamelanotide as a cosmetic sun tanning method should it eventually become an FDA-approved drug. While they are smartly approaching the FDA regulatory process for medical indications, one only has to look to the drug Botox to see an analogous drug situation. Based on the FDA clinical trial process, and assuming no untoward health risks arise during the trials, one would not anticipate clinical availability in the U.S. until at least 2012.

Dr. Barry Eppley

http://www.eppleyplasticsurgery.com

http://www.ologyspa.com

Clarian North Medical Center, Carmel, Indiana

Clarian West Medical Center, Avon, Indiana

Indianapolis