Foamix Pharmaceuticals’ (NASDAQ:FOMX) FMX103 (1.5% topical minocycline foam) has experts split over the drug’s real-world ability to protect against sunburn, despite expected FDA approval for moderate-to-severe facial papulopustular rosacea.
FMX103 likely makes the skin more sensitive to sunburn, which can result in scars for this patient population already affected by pustules on their face, said one expert.
No sunburns were reported in the two Phase III trials, which were combined into one 1,522-patient, randomised, double-blind, vehicle-controlled, pivotal program (NCT03142451), but patients likely had a skin care regimen such as regular use of sunscreen, said two experts. Outside of a trial setting, patients will not likely put sunscreen on regularly and will be prone to sunburn over the long-term, they said.
However, two other experts disagreed and said there is no risk of sunburn associated with FMX103, as this effect has not been reflected with generic oral minocycline. Instead, there is a risk of hyperpigmentation, they said.