Navigation Links
Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
Date:8/19/2007

Company on Target to File Supplemental New Drug Application in the Fourth

Quarter

FRAZER, Pa., Aug. 16 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a 12-week, Phase 3 clinical trial of FENTORA(R) (fentanyl buccal tablet) [C-II] in patients with breakthrough pain associated with a broad range of chronic non-cancer pain conditions. The study achieved statistical significance on the primary endpoint. Results across the 12 weeks of treatment showed both statistically significant and clinically relevant outcomes for patients with breakthrough pain who were already receiving and who were tolerant to opioid therapy for their underlying persistent pain. FENTORA is approved only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

"We are excited to complete our Phase 3 program with this third and final controlled study. These data show similar positive outcomes as those with FENTORA in treating breakthrough pain in opioid-tolerant patients with cancer, chronic neuropathic pain, and chronic low-back pain," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We plan to submit these data to the Food and Drug Administration in the fourth quarter as part of our supplemental New Drug Application."

About the Study

The double-blind, placebo-controlled, variable dose Phase 3 trial included 148 patients. The primary endpoint was the Sum of Pain Intensity Differences from five to 60 minutes (SPID(60)) as assessed after 12 weeks of treatment. SPID(60) is a measure that assesses analgesic efficacy of a pain medication over the first 60 minutes after treatment. Patients treated with FENTORA showed a statistically significant improvement on the primary endpoint (p<0.0001) compared with placebo. FENTORA was general
'/>"/>

SOURCE Cephalon, Inc.

Copyright©2007 PR Newswire.

Page: 1 2 3 4 5

Related biology technology :

1. Speaker announces business members of IT Task Force
2. Doyle announces technology tax credits for Berbee
3. Doyle announces new energy, global warming policies
4. Doyle announces $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/31/2014)... Colo. , July 31, 2014 ... awardee today with $25,000 to fund a translational ... inception in 2011, the gift was presented at ... Annual Meeting in Colorado Springs, ... specialize in neurointerventional approaches to neurovascular conditions, SNIS ...
(Date:7/31/2014)... New York , July 31, 2014 ... by Transparency Market Research "Electrodes for Medical Devices Market ... Scalp Electrodes, Therapeutic Electrodes - TENS, Pacemakers, Defibrillators, Electrosurgical ... Growth, Trends and Forecast, 2013 - 2019," the global ... 633.6 million in 2012 and is estimated to reach ...
(Date:7/31/2014)... DIEGO and SHENZHEN, China ... announced today the purchase of an Irys™System ... organization. BGI selected BioNano,s platform to enable comprehensive exploration ... improved assemblies for various organisms of interest, including those ... will partner together to develop new methods for multiplexing ...
(Date:7/31/2014)... IL (PRWEB) July 31, 2014 ... of automation across the U.S., increasing unemployment, depressing ... class. It is a Catch 22—we need ... but this means fewer jobs,” says economist and ... just-released Pollina Corporate Top 10 Pro-Business States for ...
Breaking Biology Technology:SNIS Foundation Bestows First Grant Award For Cutting-Edge NeuroInterventional Research 2SNIS Foundation Bestows First Grant Award For Cutting-Edge NeuroInterventional Research 3Electrodes for Medical Devices Market Expected to Reach USD 1.45 Billion Globally in 2019: Transparency Market Research 2Electrodes for Medical Devices Market Expected to Reach USD 1.45 Billion Globally in 2019: Transparency Market Research 3Electrodes for Medical Devices Market Expected to Reach USD 1.45 Billion Globally in 2019: Transparency Market Research 4Electrodes for Medical Devices Market Expected to Reach USD 1.45 Billion Globally in 2019: Transparency Market Research 5Electrodes for Medical Devices Market Expected to Reach USD 1.45 Billion Globally in 2019: Transparency Market Research 6BioNano Genomics Announces the Purchase of the Irys System by BGI 2BioNano Genomics Announces the Purchase of the Irys System by BGI 3BioNano Genomics Announces the Purchase of the Irys System by BGI 4ITRA Global Affiliate’s Pollina Corporate Top 10 Pro-Business States Minimize the Impact of Automation on Middle Class and Unemployment 2ITRA Global Affiliate’s Pollina Corporate Top 10 Pro-Business States Minimize the Impact of Automation on Middle Class and Unemployment 3ITRA Global Affiliate’s Pollina Corporate Top 10 Pro-Business States Minimize the Impact of Automation on Middle Class and Unemployment 4
... China, Oct. 14 /Xinhua-PRNewswire/ -- WuXi PharmaTech,(Cayman) Inc. ... and,medical device research and development outsourcing company with ... the addition of Jeff X.,Leng, managing director of ... Mr. Leng is replacing Sean Tong, formerly with ...
... and III ... Trials, ... ) today announced positive long-term follow-up,data from the CUSTOM I, II and ... stent (DES) system in treating,patients with coronary artery disease. The CUSTOM clinical ...
... SEATTLE, Oct. 13 Larry Corey, M.D., senior ... Disease Institute,at Fred Hutchinson Cancer Research Center, today ... the prestigious Institutes of Medicine (IOM)., Election ... highest honors in the,fields of health and medicine ...
Cached Biology Technology:WuXi PharmaTech Appoints Jeff Leng to Its Board of Directors 2Custom NX(R) Drug Eluting Stent System Continues to Demonstrate Favorable Outcomes in Challenging Patient Populations at One, Two and Three Years 2Custom NX(R) Drug Eluting Stent System Continues to Demonstrate Favorable Outcomes in Challenging Patient Populations at One, Two and Three Years 3
(Date:7/31/2014)... , July 31, 2014 Biometrics ... and innovative smart technologies; companies turn towards digital currency: ... EBAY ), Amazon.com Inc. (NASDAQ: AMZN ), ... (NASDAQ: GOOG ) and Microsoft Corporation (NASDAQ: ... focused on the growing m-commerce market, announces a video ...
(Date:7/31/2014)... nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamias, pecans, pine ... online publications, British Medical Journal Open (BMJ Open) ... BMJ Open article looked at the effects ... showed that tree nut consumption resulted in a significant ... PLOS ONE article focused on the effect of ...
(Date:7/30/2014)... Inspired by the Red Queen in Lewis Carroll,s ... of Illinois and National University of Singapore improved ... species evolve over decades to millions of years. ... model for competition, incorporates the "Red Queen Effect," ... in the 1970s, which suggests that organisms must ...
Breaking Biology News(10 mins):Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 2Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 3Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 4Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 5Smart Technology Consumer's Interest in Mobile Payment Products Grows - Company Secures Deal with Major Airline to Display Advertisements in Flight for its Next Generation Smart Wallet 6New international tree nut council study looks at nuts, diabetes and metabolic syndrome 2Classic Lewis Carroll character inspires new ecological model 2Classic Lewis Carroll character inspires new ecological model 3
... multi-disciplinary analysis that included cognitive, neurophysiologic, virologic, and molecular ... in the brain and immune cells that had infiltrated ... , "As in the rest of the body, ... control of the virus, but are unable to clear ...
... genes to survive than scientists first believed, according to new ... some of the simplest forms of life and have been ... genes ?or minimal genome ?that is needed for maintaining life. ... 'knocking out', a series of individual genes from a bacterial ...
... scientists have found that people have an ancient skeleton ... a jawless, eel-like fish. , It turns out lampreys, ... than almost all other backboned animals, may not be ... genetics that govern their skeletal development, according to findings ...
Cached Biology News:Immune response to HIV in the brain 2Minimal genome should be twice the size, study shows 2Minimal genome should be twice the size, study shows 3UF scientists reveal ancient origin of vertebrate skeleton 2UF scientists reveal ancient origin of vertebrate skeleton 3
Hamster serum...
... Kit with CyScribe GFX Purification Kit, ... purification of Cy3- and Cy5-labeled cDNA.Optimized ... cDNA labeling and purification.Flexible and optimized ... labeling reactions with either Cy3- or ...
Canine Serum...
CASPR (H-66)...
Biology Products: