Navigation Links
FDA Grants Fast Track Designation to Tioga Pharmaceuticals' Asimadoline for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Date:6/1/2011

SAN DIEGO, June 1, 2011 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. announced today that its investigational compound asimadoline has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Tioga is conducting a multi-center Phase 3 clinical trial evaluating asimadoline in D-IBS, conducted under a Special Protocol Assessment agreement with the FDA for U.S. registration.

The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. New drug applications for products in the Fast Track program ordinarily are eligible for priority review.

"The FDA's granting of Fast Track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy," said Stuart Collinson, Ph.D., Chairman and CEO of Tioga Pharmaceuticals.

For information about Tioga Pharmaceuticals' Phase 3 D-IBS trial, go to www.clinicaltrials.gov.

About Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a common, chronic gastrointestinal disorder characterized by recurrent episodes of abdominal pain or discomfort associated with a change in bowel pattern, such as loose or more frequent bowel movements, diarrhea and/or constipation. While the exact etiology of IBS is unknown, it is believed to be due to a disturbance in the interaction between the intestines, the brain and the autonomic nervous system that alters regulation of bowel motility or sensory function. IBS patients fall into different subtypes based on their predominant symptoms: IBS with diarrhea (D-IBS), IBS with constipation (C-IBS) and IBS with alternating diarrhea and constipation (A-IBS). IBS afflicts an estimated 60 million patients in the U.S. and Europe, with roughly equal prevalence of each subtype, and it is the most common diagnosis made by gastroenterologists.

About Asimadoline

Asimadoline is an orally administered small molecule that is a highly selective, peripherally restricted, kappa opioid receptor agonist. In a 596-subject Phase 2b clinical trial asimadoline demonstrated statistically significant results in the treatment of D-IBS patients with at least moderate pain across multiple parameters including endpoints of pain, urgency, frequency and bloating in both males and females. A therapeutic benefit was observed within the first month of treatment and was sustained for the three-month duration of the trial. Asimadoline appeared to be well tolerated with no adverse events occurring in a dose-dependent manner throughout the randomized, double-blind, placebo-controlled, dose-ranging clinical trial. Asimadoline has been tested in over 1,100 subjects to date and has a positive safety profile.

About Tioga Pharmaceuticals

Tioga Pharmaceuticals, Inc. is a pharmaceutical company headquartered in San Diego, CA focused on developing novel treatments for gastrointestinal diseases. Tioga is developing asimadoline in Phase 3 clinical trials for the treatment of diarrhea-predominant irritable bowel syndrome (D-IBS). Ono Pharmaceutical Co, Ltd. licensed from Tioga exclusive rights to develop and commercialize asimadoline in Japan, where Phase 1 trials are currently underway, as well as South Korea and Taiwan. For more information about Tioga Pharmaceuticals, please visit www.tiogapharma.com.


'/>"/>
SOURCE Tioga Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
2. GlaxoSmithKline To Post Quarterly US Grants Report
3. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
4. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
5. Repligen Receives Research Grants to Support Friedreichs Ataxia Development Program
6. Cardinal Health Invites Health Care Providers to Apply for $1 Million in Grants to Fund Patient Safety Initiatives
7. EMEA Grants Kiadis Pharma Lead Product ATIR(TM) Orphan Drug Designation
8. Isis Announces Award of Up to $8.4 Million in New Government Grants and Contracts to Its Ibis Biosciences Subsidiary for Pathogen Detection and Human Forensics
9. Nasdaq Grants VirtualScopics Request for Continued Listing
10. InNexus Biotechnology Receives Patent Grants in Europe
11. New Young Investigator Grants for Probiotics Research Announced
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... ... May 25, 2016 , ... The Ankle Plating ... options designed to address fractures of the distal tibia and fibula. This system ... Ankle Plating System 3 is composed of seven plate families that span the ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... WEDI, the ... information exchange, today announced that Charles W. Stellar has been named by the WEDI ... CEO since January 2016. As an executive leader with more than 35 years of ...
(Date:5/24/2016)... 2016   MedyMatch Technology Ltd ., the data analytics ... decision support tools in the emergency room, announced today that ... Advanced Technology Industries (IATI) BioMed Conference. The ... 15th National Life Sciences and Technology Week, and is being ... in Tel Aviv, Israel . Gene ...
(Date:5/23/2016)... ... May 23, 2016 , ... PrecisionAg® Media has released its ... Beyond. The paper outlines the key trends that are creating both opportunities and ... a lot of highs and lows as the precision agriculture market has grown ...
Breaking Biology Technology:
(Date:3/29/2016)... Florida , March 29, 2016 ... the "Company") LegacyXChange "LEGX" and SelectaDNA/CSI Protect are pleased ... in ink used in a variety of writing instruments, ... Buyers of originally created collectibles from athletes on LegacyXChange ... forensic analysis of the DNA. Bill ...
(Date:3/21/2016)... WAKEFIELD, Massachusetts , March 22, 2016 ... and facial recognition with passcodes for superior security ... MESG ), a leading provider of secure digital communications ... pilot their biometric technology and offer enterprise customers, particularly ... provide secure facial recognition and voice authentication within a ...
(Date:3/15/2016)... , March 15, 2016 Yissum Research ... the technology-transfer company of the Hebrew University, announced today ... remote sensing technology of various human biological indicators. Neteera ... $2.0 million from private investors. ... on the detection of electromagnetic emissions from sweat ducts, ...
Breaking Biology News(10 mins):