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 $80M renewable energy strategy
5. GE announces first installation of Discovery VCT
6. UWM announces winners of RGI awards
7. Third Wave announces two senior management appointments
8. Mirus announces new method for making antibodies
9. Merge announces sofware updates, upcoming acquisition
10. Small Tree announces ethernet solution for Apple Xserv G5
11. TEKLYNX International announces new RFID software
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... JOSE, Calif. , Aug. 20, 2014 /PRNewswire-iReach/ ... highlights the transformative collaboration between the school,s bioengineering ... As part of the Intel® Software Academic Program, ... computer sciences and the human body.  ... The study exhibits the work of Dr. ...
(Date:8/20/2014)... (PRWEB) August 20, 2014 ... released today including improvements to the enterprise replication ... connectors for Lucene, SOLR and Elasticsearch. This release ... this high performance triplestore – GraphDB™ was formerly ... in deploying the only mature enterprise resilient RDF ...
(Date:8/19/2014)... , Aug. 19, 2014 Research and Markets  has ... - Global Strategic Business Report" report to their offering. ... Tissue Culture Supplies in US$ Thousands by the following Product Segments: ... analytics for the US, Canada , ... , and Latin America . Annual estimates ...
(Date:8/19/2014)... 2014 Research and Markets  has announced the ... Global Strategic Business Report" report to their offering. ... Oxide Fuel Cells (SOFCs) in US$ Thousands. The report provides ... , Europe , Asia-Pacific ... provided for the period 2012 through 2020. Market data and ...
Breaking Biology Technology:Intel and University of San Diego Bioengineering Department Release Case Study on Health Sciences Research 2Ontotext Improves Its RDF Triplestore, GraphDB™ 6.0: Enterprise Resilience, Faster Loading Speeds and Connectors to Full-Text Search Engines Top the List of Enhancements 2Ontotext Improves Its RDF Triplestore, GraphDB™ 6.0: Enterprise Resilience, Faster Loading Speeds and Connectors to Full-Text Search Engines Top the List of Enhancements 3Ontotext Improves Its RDF Triplestore, GraphDB™ 6.0: Enterprise Resilience, Faster Loading Speeds and Connectors to Full-Text Search Engines Top the List of Enhancements 4Global Cell and Tissue Culture Supplies - Strategic Business Report 2014 2Global Solid Oxide Fuel Cells (SOFCs) - Strategic Business Report 2014 2
... ZymoGenetics, Inc. (Nasdaq:,ZGEN) announced that the company ... update on the regulatory review of recombinant thrombin,(rThrombin). ... on August 22 at 5:00,p.m. Eastern Time by ... the call approximately 10 minutes prior to,the scheduled ...
... Missourians Introduce New Ballot Initiative to Pursue Cures for Patients, ... without involving controversial Human Cloning, WASHINGTON, Aug. ... Missouri to ensure that taxpayer funds,support cures for patients, without ... Research Council, issued the,following statement on the new initiative, Cures ...
... The U.S. Food and Drug,Administration (FDA) today approved ... ages 13-17 and for the short-term,treatment of bipolar ... I disorder in children and adolescents ages 10-17. ... more than 430 adolescents,ages 13-17, in the treatment ...
Cached Biology Technology:ZymoGenetics Will Hold Conference Call Today at 5:00 p.m. Eastern Time to Provide Update on rThrombin 2FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania 2FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania 3
(Date:8/20/2014)... bags could one day be made out of cocoa, ... now reporting. The novel process they developed and their ... agricultural and plastic waste problems, appear in the ACS ... Bayer and colleagues at the Italian Institute of Technology ... 2012, its production reached 288 million tons worldwide, but ...
(Date:8/20/2014)... When a colony of honeybees grows to about 4,000 ... reproductive cycle: the building of a special type of ... team of experts from the Department of Neurobiology and ... what starts the reproductive cycle of honeybee colonies. The ... The Science of Nature . , Reproduction isn,t ...
(Date:8/20/2014)... POINT ROBERTS, Washington , August 20, 2014 ... Addressing Security Concerns in the Payment Industry?   ... leading sectors including biometrics, issues commentary from analysts and experts ... Peaslee , Managing Partner at Thrive Analytics, Isabelle Moeller ... CEO of NXT-ID, Inc. (OTCBB: NXTD) ( OTCQB:NXTD ), a ...
Breaking Biology News(10 mins):Worker bees 'know' when to invest in their reproductive future 2Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 2Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 3Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 4Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 5Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 6Digital Wallets for a Digital World - the Players and the Concerns for Consumer Adoption 7
... the Institute for Stem Cell Biology and Medicine have demonstrated ... be genetically manipulated and coaxed to develop into mature T-cells, ... The study, to be published the week of July 3 ... Academy of Sciences, found that it is possible to convert ...
... skyrocketed from 497 cases reported in 1982 (the first year ... , Lyme disease, like other zoonoses, is ... a blood meal from a vertebrate host. In the eastern ... blacklegged ticks, Ixodes scapularis, which feed on a wide variety ...
... University of North Carolina at Chapel Hill has identified ... potentially dangerous interactions with certain medications. , For almost ... and pharmacists to avoid grapefruit juice if they are ... control blood pressure or lower cholesterol. Studies have shown ...
Cached Biology News:UCLA researchers develop T-cells from human embryonic stem cells 2A new view on Lyme disease: Rodents hold the key to annual risk 2A new view on Lyme disease: Rodents hold the key to annual risk 3Study identifies substances in grapefruit juice that interact dangerously with some drugs 2
TEMPLIPHI HT SEQ AMPL KIT, 1 EA. Category: Sequencing Template Amplification....
This Malachite Green Phosphate Detection Kit...
Request Info...
1+ mg expected yield of purified protein, expressed in insect cells - excludes cDNA...
Biology Products: