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Japan Ministry of Health, Labour and Welfare approves functional dyspepsia medication

The Ministry of Health, Labour and Welfare in Japan has approved Acofide tablets 100mg (acotiamide hydrochloride hydrate), jointly developed by Zeria Pharmaceutical and Astellas Pharma, for the treatment of functional dyspepsia (FD).

New chemical entity acotiamide hydrochloride hydrate that inhibits peripheral acetylcholinesterase activities was invented by Zeria.

Acofide works by suppressing the degradation of acetylcholine that is believed to play a crucial role as neurotransmitter in regulating gastrointestinal motility.

By improving impaired gastric motility and delayed gastric emptying, the new medication targets subjective symptoms of FD including postprandial fullness, upper abdominal bloating, and early satiation in addition to improving patinet’s QOL.

Acofide is the first FD medication in the world to demonstrate efficacy in FD patients diagnosed with Rome III.

The companies will co-promote the product under a co-development and co-marketing agreement signed in March 2008 for Acofide.