Approved as SCENESSE (afamelanotide) — a subcutaneous implant to increase pain-free light exposure in adults with erythropoietic protoporphyria (EPP), FDA approval Oct 8, 2019.
Melanotan 1 and the FDA-approved drug afamelanotide are the same molecule — a synthetic, metabolically stabilized analogue of alpha-melanocyte-stimulating hormone. It binds and activates the melanocor...
Melanotan 1 and the FDA-approved drug afamelanotide are the same molecule — a synthetic, metabolically stabilized analogue of alpha-melanocyte-stimulating hormone. It binds and activates the melanocortin-1 receptor (MC1R) on melanocytes, stimulating eumelanin production independent of ultraviolet exposure. In erythropoietic protoporphyria, the resulting increase in skin melanin raises the threshold for the painful phototoxic reactions caused by circulating protoporphyrin IX.
Expert Review of Clinical Pharmacology · 2021
Post-approval review reporting real-world effectiveness meeting or exceeding trial data, with headache, fatigue, and nausea as the common adverse events.
View Source →American Journal of Clinical Dermatology · 2016
Reviews Phase III trial data confirming MC1R agonism increases sunlight tolerance and delays symptom onset with good tolerability; headache was the most common adverse effect.
View Source →New England Journal of Medicine · 2015
Two pivotal double-blind, placebo-controlled trials found afamelanotide implants significantly increased pain-free sunlight exposure and reduced phototoxic reactions versus placebo, with improved quality of life — the trials underlying FDA approval.
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