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Home Business Pharmacy

Astellas Receives Approval for a Supplemental New Drug Application for Irribow/Irribow OD

The FINANCIAL by The FINANCIAL
May 27, 2015
in Pharmacy
Reading Time: 1 min read
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The FINANCIAL — Astellas Pharma Inc. on May 26 announced that it received approval for a supplemental new drug application for the indication of the diarrhea-predominant irritable bowel syndrome 1) in female patients for “Irribow Tablets 2.5µg / 5µg and Irribow OD 2) Tablets 2.5µg / 5µg (generic name: ramosetron hydrochloride)” from the Ministry of Health, Labour and Welfare in Japan.

In October 2008, Astellas launched Irribow Tablets with the indication of diarrhea-predominant irritable bowel syndrome in male patients in Japan, and launched the orally disintegrating tablet Irribow OD Tablets for the same indication in January 2014. With this approval, Irribow/Irribow OD tablets are indicated for the treatment of diarrhea-predominant irritable bowel syndrome, allowing the use of both products for female patients suffering from this disease, according to Astellas Pharma.

Irribow Tablets / Irribow OD Tablets are a serotonin 5-HT3 receptor antagonist discovered by Astellas. Serotonin is a neurotransmitter which plays a key role in gastrointestinal motility, intestinal water secretion and sensation. Stress stimulates serotonin release and activates 5-HT3 receptors on the enteric nerves, which accelerates intestinal transit, resulting in diarrhea. In addition, an increase in intracolonic pressure also stimulates serotonin release and activates 5-HT3 receptors on abdominal visceral afferent nerve endings that signal pain to the central nervous system. Irribow Tablets / Irribow OD Tablets improve abnormal defecation associated with the acceleration of intestinal transit by selectively inhibiting 5-HT3 receptors. The drug also improves abdominal pain and visceral hypersensitivity by inhibiting visceral nociceptive pain signaling.

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Astellas expects that the additional indication for Irribow Tablets / Irribow OD Tablets will provide a new treatment option for female patients suffering from irritable bowel syndrome.

 

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