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FDA declines approval for oral Methylene Blue tablet
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The FDA said it cannot approve the new drug application for Methylene Blue MMX, according to the manufacturer Cosmo Pharmaceuticals.
Methylene Blue MMX is an oral tablet intended to help identify adenoma during colonoscopy.
“We are extremely disappointed for all patients looking for more effective colonoscopy and we strongly disagree with the FDA conclusions,” Alessandro Della Chà, CEO of Cosmo Pharmaceuticals said in a press release. “This decision fails to consider the benefit-risk of Methylene Blue MMX and the high unmet medical need.”
Investigators tested the blue dye tablet and released the results ahead of DDW 2018. They found the tablet was effective in increasing adenoma detection rate by 9% compared with a control group. Researchers also completed a previous phase 3 trial of the tablet in 2016.
The company reported in the press release that the FDA did not think the study’s findings were “robust” enough despite Methylene Blue’s statistically significant outcome. The FDA reportedly urged for an additional phase 3 trial to confirm the efficacy of the dye tablet.
“We believe the concerns raised by the FDA are fully addressable, thus we will work to have a meeting with the FDA as quick as possible,” Chà said in the press release.
Disclosures: Chà is employed by Cosmo Pharmaceuticals.