IS MELANOTAN safe to use?

MELANOTAN the BARBIE DRUG

THE CASE

Melanotan is any analog of the naturally ocurring hormone, alpha-melanocyte stimulating hormone (MSH). The main action of MSH is to stimulate the production of melanin in the skin and hair, making them darker. Melanotan has been called the "Barbie drug", because it purportedly makes you tanned, thin and horny. There are at least three synthetic melanotan compounds, called melanocortin agonists, under development.

Melanotan-I

Melanotan-I is being developed by the Australian company EpiTan, now known as Clinuvel Pharmaceuticals Ltd. It presently has the catchy name of CUV-1647. They are battling with some rules:

Regulatory approval requires that their product is demonstrated in over 1000 patients. So far they have trialled it in 167. Their struggle is that you cannot register a medicine for "sunburn" or "tanning" so they have had to seek out disorders to which it can be applied. They have chosen immuno-compromised patients susceptible to Actinic Keratosis (Solar Keratosis) which can lead to cancer.

They are also considering trialling it for rosacea. Clinuvel does not expect to achieve registration any time soon, possibly in early 2009. The company has also had to ward off imposters, importing products that infringe their copyrights. See

AUSTRALIAN CUSTOMS NOTICE NO. 2007/49 Notices of Objection to Importation Trade Marks Act 1995 epitan and Melano Tan 3/07/20007

When it is released Melanotan-I will be administered by subcutaneous implant - so don't try this at home folks.

Melanotan-II

This compound was being marketed as a sexual stimulant and for sunless tanning. It is a cyclic heptapeptide. The evidence for it's aphrodisiac efficacy was largely anecdotal, but biochemically likely. On 05/09/2007 the FDA issued a warning:

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc. in Hendersonville, Tenn. for the illegal sale and marketing of the product Melanotan II, which is not FDA-approved, on Melanocorp's Web site. 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.

"This product is being mislabeled, marketed and sold illegally as a preventative against skin cancer and as a tanning agent," said Steven Galson, M.D., M.P.H. director of FDA's Center for Drug Evaluation and Research. "Protecting the public from unapproved products such as this that make unsubstantiated claims and may pose a health risk is a top priority at the FDA."

The FDA cautions consumers about injecting any substance, particularly products that are not FDA-approved, into their bodies without the oversight of a licensed health care provider.

In Australia the Melanotan-II website copout says

Unless otherwise stated, Melanotan-II is intended solely for in-vitro research purposes, It is the responsibility of the buyer to assure that any products purchased from Melanotan-II Australia, including Melanotan-II are approved for use by the TGA and/or their states Misuse of Drugs Act, if applicable.

It is the buyers sole responsibility to ensure that the use or application of MT-II does not breach or infringe any patent, copyright or trademark in the state or territory of the consumer.

The buyer acknowledges that there may be risks involved with consumption or distribution of these products. The listing of Melanotan II on this site does not constitute a license to its use in infringement of any patent. All buyers agree and acknowledge that through their own research and study they are fully aware and knowledgeable about the following: · Government regulations regarding the use of and exposure to Melanotan-II. · The health and safety hazards associated with the handling of Melanotan-II. · The necessity of adequately warning of the health and safety hazards associated with Melanotan II.

In other words the site acknowledges that Melanotan-II is not approved in Australia and it not been proven as fit for human use. It is unlikely that the sellers can absolve themselves from all legal action by the use of fine print - but nice try. The other drawback with Melanotan-II is that it must be injected. I certainly would not inject anything of unknown provenance into myself. At least the water is labelled!

A quick trawl around the Internet uncovered many sites selling Melanotan-II, all with the proviso that their product was not intended for human use. They also extol the virtues and give instructions for use.

MELANOTAN-II AS SOLD - in UNLABELLED VIALS!

Reported side-effects include nausea, flushing and the darkening of existing freckles and moles.

Bremelanotide

Bremelanotide is provisionally named PT-141 or "Passion". Research by Palatin Technologies was halted by the FDA on 30/08/2007, due to it's causing an unacceptably high blood pressure increase. The FDA was also not convinced that the risk/benefit ration was low enough. This compound was being mooted as the only known synthetic aphrodisiac and "the female Viagra". Palatin claims it works by stimulating the brain not the genitals.

It was intended to be used for treating sexual dysfunction in men, both for erectile dysfunction (ED) and impotence, and also for sexual dysfunction in women (sexual arousal disorder). Bremelanotide is compounded into a nasal spray. Despite the side effects the FDA has left the door open for Palatin to continue research into alternate uses for bremelanotide.

MY VERDICT

It would be nice if people who want enhance their body image, by displaying tanned skin, were able to achieve this without the dangers associated with UV exposure in sunlight or in solariums, but none of the melanotans are approved for human use yet.

These melanocortin agonists are promising, but still have a way to go before they can be recommended. Forget Melanotan-II, which presently has to be injected. Forget bremelanotide nasal spray which may cause dangerous high blood pressure. Your best bet is to wait for the Clinuvel (aka EpiTan) product. At least it will have been properly tested and evaluated.

UPDATE

On 17/03/2008 there were media reports that CUV1647 had been granted status as a "orphan drug", this means that it is given a cheaper "fast track" status in Europe, that should lead to phase III testing very soon. This approval only relates relates to it's use to treat the two very rare diseases listed above - not much of an income stream, but this will no doubt lead it to be used off-label as a tanning treatment.