Astellas submits sNDA for Irribow/Irribow OD in Japan

Japanese drug major Astellas Pharma (TYO: 4503) has submitted a supplemental New Drug Application for the indication of the diarrhea-predominant irritable bowel syndrome infemales for Irribow (ramosetron HCl) tablets 2.5mcg/5mcg and Irribow OD tablets 2.5mcg/5mcg to the Ministry of Health, Labor and Welfare in Japan.

In October 2008, Astellas launched Irribow with the indication of diarrhea-predominant irritable bowel syndrome in males in Japan, and launched the orally disintegrating tablet Irribow OD tablets for the same indication in January 2014. Astellas says it expects to contribute the treatment of females with the diarrhea-predominant irritable bowel syndrome by submission of this sNDA.

Irribow/Irribow OD tablets improve abnormal defecation associated with the acceleration of intestinal transit by selectively inhibiting 5-HT3 receptor. They also improve visceral hypersensitivity by suppressing the transmission of intestinal nociception.