Navigation Links
GSK and Adolor Announce Preliminary Results from Phase 3 Safety,Study of Alvimopan (Entereg/Entrareg)

n. This data is in contrast to previously conducted studies that showed a similar or lower incidence of fractures in patients receiving alvimopan relative to placebo.

Preliminary Conclusions and Next Steps

As the findings outlined were observed during the preliminary evaluation of data from Study 014, and a full analysis has not yet been completed, further details are not yet available. Additional data are being collected and further analyses, which will include all alvimopan OBD studies, will be undertaken as soon as possible to better understand these findings.

Pending completion of these analyses, the protocol for an additional Phase 3 safety and efficacy study in patients with OBD (Study 015), which had been submitted to regulatory authorities, is being withdrawn by GSK.

As a precautionary measure, GSK has taken the decision to stop Study 101684, an extension of Study 008 in a cancer pain population, which currently has 15 patients receiving treatment. Clinical investigators involved in this study have been informed.

"Patient well-being is always our primary concern. These unexpected findings are not yet fully understood and require further analyses to ascertain the significance of the data. We are working to gain a better understanding of these findings, which will help guide our future development," said Yvonne Greenstreet, Senior Vice President, Research and Development, GlaxoSmithKline.

Adolor has also suspended enrollment in Study 228 in rotator cuff surgery patients, a co-administration study being conducted as part of Adolor's Combination Product Development Program, until a more complete understanding of these data are available. Clinical investigators involved in these studies are being informed. GSK and Adolor currently have no other ongoing studies with alvimopan.

"We continue to believe in the clinical benefit of Entereg and look forward to the further analyses of these preliminary Study 014 results,"
'"/>




Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
2. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
5. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
6. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
7. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
8. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
9. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. Inspire Announces Webcast of Presentation at C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
Post Your Comments:
(Date:9/12/2014)... DALLAS , September 12, 2014 ... Cans Market by Application [Beverages (Alcoholic, CSD, Sports & ... Food, Pet Food, Meat & Seafood)], by Material ... published by MarketsandMarkets, defines and segments the Food ... projections of each application in terms of volumes ...
(Date:9/12/2014)... , Sept. 12, 2014  Royal Philips (NYSE: ... number of innovations at ASTRO,s 56th Annual Meeting ... solutions that increase workflow automation, confidence, consistency and accuracy ... and enhancing patient-centric care, these radiation oncology solutions underscore ... a more personalized approach to medicine. "Philips ...
(Date:9/12/2014)... DUBLIN , Sept. 12, 2014 Research ... Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast - ... cancer is the most common cancer among women in both ... was in double digit Billion US$ for 2013. ... cancer screening globally. China is expected ...
Breaking Medicine Technology:Food & Beverage Metal Cans Market Worth $49.20 Billion by 2019 2Food & Beverage Metal Cans Market Worth $49.20 Billion by 2019 3Food & Beverage Metal Cans Market Worth $49.20 Billion by 2019 4Philips Demonstrates Commitment to Radiation Oncology Solutions at ASTRO 2014 2Philips Demonstrates Commitment to Radiation Oncology Solutions at ASTRO 2014 3Breast Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast - Worldwide 2Breast Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast - Worldwide 3Breast Cancer Screening (Mammography, MRI & Ultrasound) Market & Forecast - Worldwide 4
... March 7, 2011 Ajinomoto Co., a leader ... safe, effective nutraceutical solutions, has announced that its ... federal trademark registration, (®), on the Principal Register ...  The trademark is the latest milestone for Capsiate ...
... 7, 2011 HGI Global Holdings, Inc., a leading ... today announced the appointment of Michael B. Petras, Jr. ... Mr. Petras, 43, joins HGI from GE Lighting, ... (NYSE: GE ) where he served as ...
Cached Medicine Technology:Ajinomoto Co.'s Capsiate Natura® Reaches New Milestone 2Michael Petras, Former CEO of GE Lighting, Named CEO of Cleveland-Based Specialty Medical Supplies Leader 2Michael Petras, Former CEO of GE Lighting, Named CEO of Cleveland-Based Specialty Medical Supplies Leader 3
(Date:9/13/2014)... Over the past five years, ... Australia have shown signs of struggle. “The ... goods has caused Australian consumers to turn away ... IBISWorld industry analyst Ryan Lin. This trend has ... health consciousness, which has alerted the Australian population ...
(Date:9/13/2014)... MillionaireSinglesDating.com is a millionaire dating site ... dating services provider, which also launched the leading ... daddy site , SugarDaddyMeet.com, and the leading ... recently reached 2 million users milestone. , MillionaireSinglesDating.com ... include CEOs, lawyers, doctors, pro athletes, models and ...
(Date:9/13/2014)... Hills, CA (PRWEB) September 13, 2014 Bedros ... and renowned fitness marketing coach , has always been ... people think Groupon’s most useful days are over, but the ... using it may need to change. , “A lot of ... some quick income,” says Keuilian. “They run a special and ...
(Date:9/13/2014)... Happiness is a choice that can transform lives ... That's what LWell believes thanks to Joana U-Ming ... life coach who has loved fitness and has been practicing ... "Happiness is a Choice" seminar at its Yorktown, Va. location ... event is being offered free as a gift to the ...
(Date:9/13/2014)... The number of retail customers estimated to have ... is staggering, just look at some of the big names ... The New York Times, with Target and Home Dept alone ... current pace of these huge retailer data breaches continues to ... can it really be before every consumer in America finds ...
Breaking Medicine News(10 mins):Health News:Confectionery Manufacturing in Australia Industry Market Research Report Now Available from IBISWorld 2Health News:Confectionery Manufacturing in Australia Industry Market Research Report Now Available from IBISWorld 3Health News:MillionaireSinglesDating.com Reaches 2 Million Users Milestone 2Health News:Renegade Fitness Marketing Expert Reveals How Personal Trainers Can Use Groupon More Effectively to Sign New Clients 2Health News:Renegade Fitness Marketing Expert Reveals How Personal Trainers Can Use Groupon More Effectively to Sign New Clients 3Health News:“Happiness is a Choice” Life Coaching Seminar Open to Community 2Health News:“Happiness is a Choice” Life Coaching Seminar Open to Community 3Health News:Hacking Whales of the Retail World Can Start With Just One Little Phish 2Health News:Hacking Whales of the Retail World Can Start With Just One Little Phish 3Health News:Hacking Whales of the Retail World Can Start With Just One Little Phish 4Health News:Hacking Whales of the Retail World Can Start With Just One Little Phish 5
... Drugs that Facilitate and/or Prevent Diabetes//. ... develop new-onset diabetes than those who don’t have hypertension, ... recent weight gain, or stronger family history of diabetes ... have known since 1958 that some drugs used to ...
... to tell their partners// to seek treatment and, in ... help reduce infection rates, says a new study on ... of managing most curable sexually transmitted infections, but the ... difficult. ,Researchers analysed 14 studies involving ...
... The All India Institute of Medical Sciences (AIIMS) Friday become ... the most advanced four-arm robot - Da Vinci S. ... in July last year and today we completed the 100th ... in Asia," said Ashok K. Hemal, a senior professor at ...
... Wake Forest University Baptist Medical Center are helping to ... sites that will test 3,000 patients in an effort ... failure patients. ,Though doctors have promoted the value ... “exercise training has not been definitively established as safe ...
... to save the day during life-threatening allergic reactions// and ... amongst medics. ,Wellington-based Mayne Pharma, New ... German manufacturers. This has led to the interruption in ... ,Hospitals in New Zealand, hope to tide over this ...
... Edmonton’s Capital Health Region.// As per this, information on blood ... she visits a hospital, clinic or a doctor which is ... be used to detect diabetes and treat the illness if ... manifest itself as blindness, kidney failure, amputation of limbs etc. ...
Cached Medicine News:Health News:Differences Between BP Medicines and Newly-Diagnosed Diabetes Identified 2Health News:Differences Between BP Medicines and Newly-Diagnosed Diabetes Identified 3Health News:New International Study to Test Exercise in Heart Failure Patients 2Health News:New International Study to Test Exercise in Heart Failure Patients 3
... The 5mm AEM Laparoscopic Instruments incorporate ... AEM Instruments are shielded and monitored to ... of the instrument caused by insulation failure ... risk. The protective shield built into all ...
... incorporate a layered design unique in the ... to prevent stray electrosurgical burns along the ... failure or capacitive coupling; a well-documented patient ... all AEM Instruments provides a neutral return ...
... incorporate a layered design unique in the ... to prevent stray electrosurgical burns along the ... failure or capacitive coupling; a well-documented patient ... all AEM Instruments provides a neutral return ...
... The 5mm AEM Laparoscopic Instruments incorporate a ... Instruments are shielded and monitored to prevent ... the instrument caused by insulation failure or ... The protective shield built into all AEM ...
Medicine Products: