Afamelanotide

(Scenesse®)

Afamelanotide

Drug updated on 12/11/2024

Dosage FormImplant (subcutaneous; 16 mg)
Drug ClassMelanocortin 1 receptor (MC1-R) agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP).

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Summary
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  • This summary is based on the review of one systematic review/meta-analysis. [1]
  • Afamelanotide (Scenesse) demonstrated a moderate positive effect on skin photosensitivity in individuals with erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), with its efficacy comparable to inorganic sunscreen; however, organic sunscreens and various oral treatments (e.g., beta-carotene, vitamin C) showed no effect.
  • The studies primarily focused on individuals with EPP or XLP, highlighting the relevance of these findings for this population, which experiences skin photosensitivity due to the accumulation of protoporphyrin IX (PPIX).
  • The safety profile of afamelanotide (Scenesse) was noted as favorable; however, specific safety outcomes or adverse effects were not detailed in the study, indicating a lack of comprehensive safety data.
  • No significant safety concerns or adverse effects were highlighted in the reviewed studies, particularly concerning individuals with EPP or XLP.
  • The studies focused on individuals with EPP or XLP, demonstrating that afamelanotide effectively improves skin photosensitivity, which is particularly relevant for these populations due to the accumulation of PPIX.

Product Monograph / Prescribing Information

Document TitleYearSource
Scenesse (afamelanotide) Prescribing Information.2023Clinuvel Inc., Burlingame, CA

Systematic Reviews / Meta-Analyses