Melanotan I

Melanotan I is afamelanotide, and that is unusual for this reference: the thing being sold really is the approved drug. One chemical database record carries Afamelanotide, Melanotan I, Melanotan-1 and Scenesse in a single synonym list, its formula is the formula printed on the approved label, and the weights agree to a decimal place. It is a chain of 13 amino acids copying the body's own signal for making brown black pigment. What differs is not the molecule but the product. The approved thing is a solid rod, about 1.7 centimetres long, holding 16 mg of drug in a plastic the body dissolves and absorbs, placed under the skin by a physician the licence holder has trained and accredited, once every two months, for a rare disease in which light causes burning pain. What circulates is a vial of powder people reconstitute and inject themselves, for a tan.

It switches on the receptor that tells pigment cells to make eumelanin, the brown black pigment, which is why a tan follows and why the approval is about light. The point of the approved product is not the molecule but the shape of the exposure. The peptide's own half life is short, about 30 minutes on the European label and 0.8 to 1.7 hours measured after injection under the skin, so a single injection is gone within a day. The rod exists to stop that: most of the drug is released in the first 48 hours, blood levels are below the limit of measurement by day 10, and the regulator's review expected total exposure of 25 to 35 days a year across five implants. Pigment then outlasts the drug by weeks, which is the trap for anyone judging by the mirror. A radiator stays warm long after the boiler has cut out, and touching it tells you nothing about whether the boiler is running.

Tanning, and protection from sunburn. What is approved is neither. Both labels cover one rare inherited light sensitivity disease, and both pivotal trials measured hours spent in sunlight without pain rather than how brown anybody got. Neither approval mentions tanning, cosmetic use or healthy adults. The injected record in healthy volunteers is real but old and small, four studies I found between 1997 and 2006, and the tanning indication does not appear again in anything I searched.

The costly mistake is reading an approval for one product as an approval for another. A vendor page can point at the chemical database, point at the label, and be telling the truth about the molecule, and everything after that sentence is transferred from a rod to a vial. The approval is also thinner than the pages suggest, and both regulators say so in their own documents. One pivotal trial carried the European authorisation after two others were dropped following an inspection; the headline figure of 24 extra pain free hours across six months, and its range from 0.3 to 50.3, come from a method the assessment report says was specified after the data were in, printed under a heading for post hoc analyses; significance on the protocol primary endpoint came only on a one sided test; and seven members of the committee signed a divergent position against granting it without specific obligations.

The implant's trial record is unremarkable and should be said first: across three placebo controlled trials in 244 adults with the disease, 125 received the drug and 119 a dummy implant, with implant site reactions in 21 percent against 10 and nausea in 19 against 14. The concerns are about pigment. Darkening of existing moles is on both labels, both labels recommend a full body skin examination every six months, and recommend is their word rather than require. The American regulator granted a waiver from carcinogenicity studies in March 2017, its review saying there is no accurate animal model for whether this drug could induce melanomas, and required an eight year registry of treated patients in their place, with skin cancer as one of two primary adverse events of interest and a final report due March 2031. All of that describes a drug given three to five times a year under a specialist's eye. None of the label's guards travels with a grey market vial.