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.
This was done by 2004.As of 2010, afamelanotide was in Phase III trials for erythropoietic protoporphyria and polymorphous light eruption and was in Phase II trials for actinic keratosis and squamous cell carcinoma; as well, it had been trialled in phototoxicity associated with systemic photodynamic therapy and solar urticaria. Clinuvel had also obtained orphan drug status for afamelanotide in the US and the EU by that time.In May 2010, the Italian Medicines Agency (AIFA, or Agenzia Italiana del Farmaco) approved afamelanotide as a treatment for erythropoietic protoporphyria.In January 2015, afamelanotide was approved by the European Medicines Agency (EMA) in Europe for the treatment of phototoxicity in people with EPP.There were three trials that evaluated afamelanotide in those with erythropoietic protoporphyria (EPP).In Trial 1, subjects received afamelanotide or vehicle implant every two months and were followed for 180 days. Subjects recorded every day the number of hours spent in direct sunlight and whether they experienced any phototoxic pain that day. The trial measured the total number of hours over 180 days spent in direct sunlight between 10 am and 6 pm on days with no pain.In Trial 2, subjects received afamelanotide or vehicle implants every two months and were followed for 270 days. Subjects daily recorded the number of hours spent outdoors as well as whether "most of the day" was spent in direct sunlight, shade, or a combination of both, and whether they experienced any phototoxic pain that day.