Navigation Links
Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline
Date:9/2/2014

DUBLIN, Sept. 2, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D).  Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO

"The NDA filing of eluxadoline marks an important step forward for this potential first-in-class treatment, which demonstrates our commitment to helping patients suffering from this debilitating condition," said Paul Covington, MD, Senior Vice President, Clinical Operations & Development at Furiex Pharmaceuticals, a subsidiary of Actavis.  "We are pleased that the FDA has granted eluxadoline a priority review, setting the stage for us to bring this potential  new treatment option to patients promptly." 

The NDA submission for eluxadoline is based on the results of two Phase III clinical studies that met their primary endpoints. The 12- week efficacy portion of the studies demonstrated significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses.

Eluxadoline was well-tolerated and the adverse events (reported in greater than 5% of eluxadoline-treated patients and at an incidence greater than placebo) consisted of constipation (7.4% (75 mg) and 8.6% (100 mg) vs 2.5% placebo),  nausea (8.1% (75mg) and 7.5% (100mg) vs 5.1% placebo) and abdominal pain (4.1% (75mg) and 5.0% (100mg) vs 2.7% placebo).  The studies consisted o
'/>"/>

SOURCE Actavis plc
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Watson to Acquire Actavis Group for EUR4.25 Billion
2. Actavis Launches First Generic Equivalent of Requip® XL (Ropinirole Extended-Release Tablets)
3. Actavis Launches Generic Equivalent of Adalat® CC 90mg (Nifedipine Extended-Release Tablets, USP)
4. Watson and Actavis Receive FTC Second Request
5. Watson Announces New Name -- Actavis -- for Global Operations
6. Watson Pharmaceuticals, Inc. is Now Actavis, Inc.
7. Actavis, Inc. to Host Fourth Quarter 2012 Earnings Conference Call and Webcast
8. Actavis, Inc. to Present at the RBC Capital Markets Healthcare Conference
9. Actavis Full Year 2012 Net Revenue Increases 29% to $5.91 Billion
10. Actavis, Inc. to Present at the Cowen & Company 33rd Annual Health Care Conference
11. Actavis, Inc. to Present at the Barclays 2013 Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/22/2015)... UPI ), a medical device company that develops, manufactures ... today reported financial results for the fiscal 2015 third ... the Company,s Urgent ®  PC Neuromodulation System grew 14.5% ... compared to $3.9 million in the third quarter of ...
(Date:1/22/2015)... AMGN ) today announced that it will report its ... 27, 2015, after the close of the U.S. financial markets. The ... community at 2 p.m. PT. Participating in the call from Amgen ... officer, and other members of Amgen,s senior management team. ...
(Date:1/22/2015)... 2015 Increasing sophistication among enterprise buyers of language ... in 2015, says Moravia CMO, Renato ... by market research firm Common Sense Advisory, 15 percent ... translation and localization needs. "From a language industry perspective, ...
Breaking Medicine Technology:Uroplasty Reports Record Revenue in Fiscal Third Quarter 2Uroplasty Reports Record Revenue in Fiscal Third Quarter 3Uroplasty Reports Record Revenue in Fiscal Third Quarter 4Uroplasty Reports Record Revenue in Fiscal Third Quarter 5Uroplasty Reports Record Revenue in Fiscal Third Quarter 6Uroplasty Reports Record Revenue in Fiscal Third Quarter 7Uroplasty Reports Record Revenue in Fiscal Third Quarter 8Uroplasty Reports Record Revenue in Fiscal Third Quarter 9Uroplasty Reports Record Revenue in Fiscal Third Quarter 10Uroplasty Reports Record Revenue in Fiscal Third Quarter 11Uroplasty Reports Record Revenue in Fiscal Third Quarter 12Uroplasty Reports Record Revenue in Fiscal Third Quarter 13Uroplasty Reports Record Revenue in Fiscal Third Quarter 14Uroplasty Reports Record Revenue in Fiscal Third Quarter 15Uroplasty Reports Record Revenue in Fiscal Third Quarter 16Uroplasty Reports Record Revenue in Fiscal Third Quarter 17Uroplasty Reports Record Revenue in Fiscal Third Quarter 18Amgen Announces Webcast of 2014 Fourth Quarter and Full Year Financial Results 2Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
... July 12 The Iowa Health Information Technology Regional ... the single-database, integrated electronic health record (EHR), practice management and interoperability ... statewide deployment program within the federal Department of Health and Human ... , , ...
... SWARTZ CREEK, Mich. , July 12 ... privately owned specialty pharmacy, announced today that ... team. Mr. Fleckenstein will serve as the Company,s ... of Diplomat,s National Distribution Center, Patient Service Operations, ...
Cached Medicine Technology:Iowa Regional Extension Center Selects Greenway EHR Solutions 2Iowa Regional Extension Center Selects Greenway EHR Solutions 3Iowa Regional Extension Center Selects Greenway EHR Solutions 4Iowa Regional Extension Center Selects Greenway EHR Solutions 5Diplomat Specialty Pharmacy Hires Vice President of Operations 2Diplomat Specialty Pharmacy Hires Vice President of Operations 3
(Date:1/22/2015)... Boulder, Colorado (PRWEB) January 22, 2015 Four years ... is Queen – which coincided with the marriage of Avasa & ... album, THE ROAD, which is scheduled for release through White Swan ... heartfelt message that there is a sacred path available to all ...
(Date:1/22/2015)... IPSWICH, Mass. (PRWEB) January 22, 2015 ... Association (AMA) are expanding their relationship in an effort ... journals around the world. While EBSCO has long made AMA ... as a sales agent for The JAMA Network. ...
(Date:1/22/2015)... 22, 2015 JJsHouse.com is a famous dress ... the business announces its latest collection of wedding dresses ... most important issue is the wedding dress on your big ... a woman’s life. Every bride wants to find the most ...
(Date:1/22/2015)... January 22, 2015 Lower-Auto-Insurance.com has released a new ... in a car for reducing the costs of an auto ... also be able to get lower prices for their vehicle insurance ... important role in determining policy costs. Because of this, drivers ...
(Date:1/22/2015)... State Forestry Institute of Mecklenburg-Vorpommern in ... support from GEOSYSTEMS, a dedicated Hexagon Geospatial and Intergraph ... Hexagon Geospatial’s ERDAS APOLLO for cataloging, managing, ... point clouds and documents. This effort will enable the ...
Breaking Medicine News(10 mins):Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:EBSCO Expands Partnership with the American Medical Association 2Health News:EBSCO Expands Partnership with the American Medical Association 3Health News:EBSCO Expands Partnership with the American Medical Association 4Health News:Find The Most Suitable Wedding Dress At JJsHouse.com 2Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 2Health News:State Forestry Institute Mecklenburg-Vorpommern, Germany Embraces Hexagon Geospatial Technology 3
... cities has urged his 11 million residents to stop buying ... woes, state media reported Friday. ,The booming ... Hong Kong, now has more than one million cars, with ... Daily reported. ,"Stop buying cars," Xu Zongheng, the ...
... to bizarre things that can happen in that melting pot of ... is attacked savagely by her mothers boyfriend, for months. All that ... poor child, but she would not betray her lover. The ... ,,New Bedford police in Massachusetts announced Wednesday the arrests and ...
... new research by a Frankfurt University team has successfully ... birds, also use the Earth's magnetic field to sense ... the team of Prof. Dr. Wolfgang Wiltschko and Roswitha ... field, teaching them by intensive training that their mother ...
... of Nottingham are amassing an arsenal of weapons in preparation ... . ,It infiltrates hospitals as microscopic spores. Its ... it kills three times as many people every year as ... Nigel Minton in the Centre for Healthcare Associated Infections (CHAI), ...
... A new study has revealed that exercise significantly ... ,The study compared the efficiency of ... quality-of-life among the elderly; education, home safety assessment ... ,The study also examined the secondary effects of ...
... are also costing the nation a lot of money indirectly, ... . Griffith University has been working with Queensland Health and ... of sleep disorders. ,Often general practitioners do not ... with the diagnosis of sleep disorders, so they err on ...
Cached Medicine News:Health News:Boyfriend Bites Off Lip and Ear of 3-year-old Daughter of His Girlfriend 2Health News:The Hospital Superbugs 2Health News:The Hospital Superbugs 3
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: