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:8/29/2014)... Burnt Hills, NY (PRWEB) August 29, 2014 ... at Burnt Hills Veterinary Hospital are seeking candidates to ... for dogs with osteoarthritis. The ultimate goal of ... of donor stem cells into one or two arthritically ... the treated joints. , Candidates for the current ...
(Date:8/28/2014)... August 28, 2014 SPIE Fellow Glenn ... and Optical Science and Director of the Center for ... Carolina at Charlotte, and co-founder and Chairman of the ... as the 2015 Vice President of SPIE, the international ... Philip Stahl announced recent election results at the Annual ...
(Date:8/28/2014)... converters are important devices in spintronics, an electronic ... of electrons but also on their spin and ... of electric into magnetic signals and vice versa. ... from the Institute of Physics at Johannes Gutenberg ... UK, Prague, and Japan, has for the first ...
(Date:8/28/2014)... Sterlitech is proud to announce that it is ... of products . These additional products increase the ... filters with surface charges. , “We have ... membrane process testing equipment, and correspondingly, a wider demand ... Sterlitech President Mark Spatz. “The addition of Synder ...
Breaking Biology Technology:Burnt Hills Veterinary Hospital Seeks Candidates for an Investigational Study of Stem Cells for Dogs with Arthritis 2Glenn Boreman, UNC Professor and Plasmonics Co-Founder, Elected to SPIE Presidential Chain 2A new, tunable device for spintronics 2A new, tunable device for spintronics 3Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 2
... I sat with the product managers at Palm and got a ... intended to be an entry-level digital organizer for the masses of ... wanted a simple product that delivered real value. After listening to ... I leaned close to the product marketing manager and said, "You're ...
... Corp. announced today the company has signed a ... Janesville-based Internet services provider. The deal is forecast to ... revenue and to be accretive to MobilePros earnings. The ... agreements and customary closing conditions, is expected to close ...
... Florida has taken a lot of crap from the academic ... Rise of the Creative Class. To summarize, Dr. Florida says ... indicators of economic boomtowns. , ,Some of Richs indexes ... citys concentration of gays, the more likely the city is ...
Cached Biology Technology:The Palm to "de-Zire" 2The Palm to "de-Zire" 3The Creative Class from my perspective 2
(Date:8/28/2014)... FASEB MARC (Maximizing Access to Research Careers) Program ... Society of Human Genetics from October 18 22, ... meant to promote the entry of students, post doctorates ... the basic science community and to encourage the participation ... Genetics. This year MARC conferred 16 awards totaling ...
(Date:8/28/2014)... MARC (Maximizing Access to Research Careers) Program has ... Society of America,s 27th Annual Mouse Molecular Genetics ... in Pacific Grove, California. These awards are ... doctorates and scientists from underrepresented groups into the ... encourage the participation of young scientists at the ...
(Date:8/28/2014)... , Aug. 28, 2014  Privacy Advocate and Senior ... Jennifer Lynch , joins the lineup of biometric and ... annual Biometrics UnPlugged Executive Summit in Tampa, ... Previously announced speakers include Steven Rahman, Director, Technology and ... Sector at Experian. The theme of this year,s event ...
Breaking Biology News(10 mins):Biometrics UnPlugged Welcomes the Electronic Frontier Foundation's Jennifer Lynch to the Mobility at the Crossroads of Commerce and Privacy Summit 2
... Using an elaborate sleuthing system they developed to ... scientists have discovered that common but hard-to-see sugar switches ... sugar switches are so abundant and potential targets of ... implications for new treatments for a number of diseases, ...
... Monash University biochemists have found a critical piece in ... evolved millions of centuries ago. The team, from ... by which bacteria developed into more complex cells and ... evolutionary timeline than previously thought. Team leader ...
... Children who are especially reactive to stress are ... health problems than their peers. But a new longitudinal ... likely to do well when they,re raised in supportive ... of British Columbia, the University of California, San Francisco, ...
Cached Biology News:Sweet! -- sugar plays key role in cell division 2An answer to another of life's big questions 2High sensitivity to stress isn't always bad for children 2
... stainless-steel shaker flask clips, purpose-designed to firmly ... All clips are equipped with a top ... include a bottom retainer spring, and silicon ... expensive glassware. Clips include the required ...
... immuncapture enzyme-activity assay based on measurenment of ... monoclonal antibody coated microtiter plate. The procedure ... samples or controls, 2nd enzyme reaction) ... is intended for the determination of human ...
... Incubator/Shaker HT is designed for ... Incubator/Shaker HT is ideal for ... and primer extension assays. The ... as a one-cabinet model, allowing ...
... Source: Pseudomonas atlantica Description: Beta-Agarase ... RNA fragments from low-melting-temperature agarose. Beta-Agarase ... disaccharides. Tested User Friendly Properties: Heat ... 30,000 Da Optimum pH: 6.5 Purity: ...
Biology Products: