Afamelanotide

Status

FDA-approved. FDA-approved labeling exists as Scenesse, a subcutaneous implant, to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria. Labeling requires periodic full-body skin examination to monitor pigmented lesions.

What it is

A melanocortin agonist approved as an implant for a rare light sensitivity condition.

What published research measured

An analogue of alpha-melanocyte stimulating hormone, approved as a subcutaneous implant (afamelanotide, Scenesse) for erythropoietic protoporphyria. Randomized controlled trials in erythropoietic protoporphyria — a rare disorder in which sunlight causes severe pain — showed the implant increased pain-free time spent in daylight, which supported approval in Europe and the United States. It works by driving eumelanin production through the melanocortin-1 receptor rather than by blocking ultraviolet light. Because it increases pigmentation broadly it can darken existing naevi, and the approved labeling requires twice-yearly full-body skin monitoring; it is not a substitute for sun protection. It is important not to confuse this compound with the more widely circulated Melanotan II, a different and unapproved analogue with much broader melanocortin receptor activity and a substantially worse safety record.

Source

Randomized trials of afamelanotide in erythropoietic protoporphyria · FDA labeling for Scenesse

Sources

• Half-life source for Afamelanotide