The world's first oral drug to improve colonoscopy results, Methylene Blue MMX, has been approved in Europe.

Cosmo Pharmaceuticals announced that the European Commission (EC) has approved its Methylene Blue MMX, a paracetamol cosmo tablet, for the visualization of colorectal lesions in colonoscopy.
was the first approval of Methylene Blue MMX and the first approval of an oral drug to improve colonoscopy results.
photo sources: Repici A, Wallace MB, East JE, et al. Efficacy of Per-oral Methylene Blue Development for Screening Colonoscopy. Gastroenterology. 2019;156 (8): 2198-2207.e1. This approval is based on a single Phase III trial data (involving 1,249 patients) conducted by Cosmo in 20 regions worldwide.
the study reached a predetermined end point: Methylene Blue MMX had a higher detection rate (ADR) of adenomas (56.29 percent and 47.81 percent, respectively) than HDWL colonoscopies.
important secondary endpoints specified in advance show that Methylene Blue MMX can increase detection of at least one adenoma patient compared to HDWL colonoscopy without increasing false positive rate (FPR).
other endpoints, Methylene Blue MMX significantly increased detection of non-pyridrogenic (flat) lesions (the most commonly missed lesions).
: CHMP recommends that Methylene Blue MMX be approved as "a diagnostic agent to enhance the visualization of colorectal lesions in adult patients undergoing screening or colonoscopy."
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