Afamelanotide, sold under the brand name Scenesse, is a synthetic peptide and analogue of α-melanocyte stimulating hormone. It has been used to prevent skin damage from the sun in people with erythropoietic protoporphyria in the European Union since January 2015 and the United States since October 2019. As a medication, it is administered in subcutaneous implant form. Each implant lasts two months.The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication. Medical use
Afamelanotide is used in the European Union to prevent phototoxicity in adults with erythropoietic protoporphyria (EPP). Adverse effects
Very common (may affect more than 10% of people) adverse effects in people with EPP include headache and nausea. Common (between 1% and 10%) adverse effects include back pain, upper respiratory tract infections, decreased appetite, migraine, dizziness, weakness, fatigue, lethargy, sleepiness, feeling hot, stomach pain, diarrhea, vomiting, flushing and red skin, development of warts, spots and freckles, itchy skin, and reactions at the injection site. There are many uncommon (less than 1%) adverse effects. Pharmacology
Afamelanotide is thought to cause skin to darken by binding to the melanocortin 1 receptor which in turn drives melanogenesis.Afamelanotide has a half-life of 30 minutes. After the implant is injected, most of the drug is released within the first two days, with 90% released by the fifth day. By the tenth day no drug is detectable in plasma.Its metabolites, distribution, metabolism and excretion were not understood as of 2017. Chemistry
The amino acid sequence is Ac-Ser-Tyr-Ser-Nle-Glu-His-D-Phe-Arg-Trp-Gly-Lys-Pro-Val-NH2.
The trial measured the total number of hours over 270 days spent outdoors between 10 am and 3 pm on days with no pain for which "most of the day" was spent in direct sunlight.In Trial 3 subjects were randomized to receive a total of three afamelanotide or vehicle implants administered subcutaneously every two months and were followed for 180 days. Data from this trial were used primarily for assessment of side effects.The FDA approved afamelanotide based on evidence from three clinical trials (Trial 1/ NCT 01605136, Trial 2/ NCT00979745 and Trial 3/ NCT01097044) of 244 adults 18–74 years of age with EPP. The trials were conducted at 22 sites in the US and Europe.In October 2019, afamelanotide was approved by the US Food and Drug Administration (FDA) as a medicine to reduce pain caused by light exposure (particularly sunlight) as experienced by people with erythropoietic protoporphyria. Society and culture
Usage in general public
A number of products are sold online and in gyms and beauty salons as "melanotan" or "melanotan-1" which discuss afamelanotide in their marketing.Without a prescription, these drugs are not legally sold in many jurisdictions and are potentially dangerous.Starting in 2007, health agencies in various countries began issuing warnings against their use.Unlicensed and untested powders sold as "melanotan" are found on the Internet (marketed for tanning and other purposes). Multiple regulatory bodies have warned consumers that the peptides may be unsafe and ineffective. Research
Ongoing research is underway for other skin disorders. Afamelanotide causes skin to turn darker by causing skin to produce more melanin.