西亞試劑：安斯泰來推出Irribow口服崩解片

安斯泰來（Astellas）1月15日宣布，在日本推出Irribow OD片2.5ug/5ug（通用名：鹽酸雷莫司瓊，ramosetron hydrochloride），該藥為口服崩解片（orally disintegrating，OD）劑型，于2013年8月獲日本批準，作為一種新配方Irribow片，用于腹瀉型腸易激綜合征2（IBS-D）男性患者的治療。

Irribow OD片利用安斯泰來專有的藥物遞送技術WOWTAB開發(fā)，該藥在接觸口腔唾液時刻迅速崩解，因此無需喝水即可咀嚼。對于老年患者及有吞咽困難的患者來說，該藥也可以很容易地服藥，同時還可以用于任何避免喝水的情況，滿足患者的各種需求。

Irribow片是5羥色胺3（5-HT3）受體拮抗劑，由安斯泰來發(fā)現(xiàn)。5羥色胺是一種神經(jīng)遞質，與腸胃蠕動、分泌和感覺有很大關系。應激可能刺激血清素的釋放，并激活腸道神經(jīng)上的5-HT3受體，誘發(fā)腸道的加速運轉，導致腹瀉。此外，腸道內(nèi)的壓力也可誘導血清素釋放，血清素會結合神經(jīng)元終端的5-HT3受體，引發(fā)腸道痛覺并傳遞到中樞神經(jīng)系統(tǒng)。

Irribow能夠選擇性地抑制5-HT3受體，從而改善與腸道加速轉運相關的異常排便，該藥還能通過抑制腸道痛覺的傳輸，改善內(nèi)臟高敏感性。（生物谷Bioon.com）

英文原文：Astellas Pharma: Launches Irribow® OD Tablets in Japan for Diarrhea-predominant Irritable Bowel Syndrome

Tokyo, January 15, 2014 - Astellas Pharma Inc. (“Astellas Pharma”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) announced that the orally disintegrating tablet “Irribow® OD 1) Tablets 2.5µg / 5µg” (generic name: ramosetron hydrochloride) become available in Japanese market today. They were approved for an additional formulation of Irribow® Tablet with the indication of diarrhea-predominant irritable bowel syndrome 2) (“IBS-D”) in male.
 
Irribow® OD Tablet is a drug for treating IBS-D developed using WOWTAB 3) which is one of the Astellas' proprietary drug delivery technologies. It can be ingested without water since it quickly disintegrates upon contact with saliva in the mouth. It can be easily taken even by elderly patients and patients with impaired swallowing function. It is also useful for patients with avoided water consumption and meets various needs of patients. Astellas offers Gaster® D Tablet for the treatment for peptic ulcers and gastritis, Harnal® D Tablet for the treatment for functional symptoms of benign prostatic hyperplasia and Vesicare® OD Tablet for overactive bladder, which were developed with using WOWTAB technology.
 
Irribow® Tablet is a serotonin 5-HT3 receptor antagonist discovered by Astellas. Serotonin is a member of neurotransmitter which is greatly related to gastrointestinal motility, secretion and sensation. Stress may stimulate the serotonin release and activate the 5-HT3 receptors on enteric nerve, which induces the acceleration of intestinal transit resulting in diarrhea. In addition, the increase in intracolonic pressure also induces serotonin release, and it will bind to 5-HT3 receptor at the terminal of afferent neuron, causing intestinal nociceptive transmission to central nervous system.
 
Irribow® Tablet improves abnormal defecation associated with the acceleration of intestinal transit by inhibiting 5-HT3 receptor selectively. It also improves visceral hypersensitivity by suppressing the transmission of intestinal nociception.
 
Astellas expects to further contribute to irritable bowel syndrome treatment by introducing Irribow® OD Tablet which can further improve the compliance with its more convenient dosing option.
 
Upon the launch of Irribow® OD Tablet, Astellas doesn’t revise its current fiscal year (from April 1, 2013 to March 31, 2014) financial forecasts.
 
1) OD = Orally Disintegrating
2) Irritable bowel syndrome (IBS) is a functional but not organic disorder which causes abdominal pain and/or discomfort with abnormal defecation including diarrhea and constipation. These gastrointestinal symptoms persist for a long period with frequent remissions and exacerbations. Abdominal pain/discomfort and abnormal defecation are often associated with many factors such as stress, which is considered to cause the acceleration of intestinal transit resulted from the over-activation of enteric nervous system.
3) WOWTAB = Without Water Tablet
 
Product outlines are as follows:
Brand name: Irribow® OD Tablets 2.5µg / Irribow® OD Tablets 5µg
Generic name: Ramosetron Hydrochloride
Indication: Diarrhea-predominant irritable bowel syndrome in males
Dosage regimen: The recommended oral dose for adult males is 5μg of ramosetron hydrochloride, once daily. The dosage can be increased or decreased depending on the patient’s symptoms with a maximum dosage of 10 µg a day.
Package:
Irribow® OD Tablets 2.5µg: 100 Tablets (10 tablets x 10 sheets)
Irribow® OD Tablets 5µg: 100 Tablets (10 tablets x 10 sheets)
Drug Price:
Irribow® OD Tablets 2.5µg: 85.80 Yen
Irribow® OD Tablets 5µg: 140.20 Yen
Date of NHI Price Listing: December 13, 2013
Date of Launch: January 15, 2014
 
With the objective of prevention of medical accidents, Astellas has adopted the user-friendly artwork on blisters, which make it easy to identify even when PTP sheet is divided, and worked on the improvements of medicine identification with (i) print of product name and dosage on each pocket (each medicine), (ii) ingenuity of letter size and color, (iii) display of efficacy and so on.  The color and design of Irribow® OD Tablet are easy to identify for persons with impaired color vision.