Navigation Links
Cephalon Submits Supplemental New Drug Application for FENTORA
Date:11/12/2007

Indication Sought for Breakthrough Pain Associated with Chronic Pain

Conditions in Patients Who are Already Taking Opioid Medications

Around-the-Clock

FRAZER, Pa., Nov. 12 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market FENTORA(R) (fentanyl buccal tablet) [C-II] for the management of breakthrough pain in opioid tolerant patients with chronic pain conditions. Breakthrough pain is characterized by its rapid onset, moderate- to-severe intensity, and relatively short duration. According to a study published in the August 2006 issue of The Journal of Pain, up to 74 percent of patients with non-cancer chronic pain conditions treated for persistent pain, such as chronic low back and chronic neuropathic pain, will experience breakthrough pain. Currently FENTORA is approved 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 pain.

"The clinical trials supporting this submission mark the first time a pain medication has been evaluated as a treatment for breakthrough pain associated with serious chronic pain conditions other than cancer," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "We look forward to working with FDA to broaden the use of FENTORA to opioid tolerant patients with unresolved debilitating breakthrough pain."

The FENTORA sNDA includes data from three randomized, placebo-controlled clinical trials and one long-term open-label safety study with a total of 941 opioid tolerant patients. The patients in the FENTORA sNDA trials were treated for up to 18 months and had a broad range of underlying chronic pain conditions, including chronic low back and chronic neuropathic pain. In the randomiz
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7

Related biology technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Cephalon, Inc. Announces Agreement to Acquire AMRIX, A Once-Daily Extended-Release Muscle Relaxant
3. Cephalon Reinforces Important Prescribing and Dosing Information for FENTORA
4. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
5. Cephalon Quarterly Conference Call Invitation
6. Cephalon Announces Strong Third Quarter Financial Results
7. Exelixis Submits XL880 Diligence Report to GlaxoSmithKline
8. CV Therapeutics Submits Supplemental New Drug Application for Ranexa(R) (ranolazine extended-release tablets)
9. AMDL Submits Data to FDA for Clearance to Market Its DR-70(R) Diagnostic Test to Monitor Colorectal Cancer Patients
10. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
11. Barr Confirms Filing an Application With a Paragraph IV Certification for Femcon(R) FE Chewable Oral Contraceptive Product
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Niagara Thermal Products is proud to announce that ... ("B3") as the critical thermal component supplier in support ... Corps of Engineers.  B3 has developed the only comprehensive ... destroys VOCs and other chemical pollutants, allergens and organic ...
(Date:1/15/2014)... England and SAN JOSE, California ... international biotechnology company developing antibody-drug conjugates for cancer, today announced ... Board of Directors. Dr Reynolds has over 20 years, development ... Medical Officer at Seattle Genetics. "I am delighted ...
(Date:1/15/2014)... IPSWICH, England , January 15, 2014 ... to win races on the Formula 1 track could help ... between McLaren Applied Technologies (MAT), Stowhealth (a GP surgery based ... funded by healthcare provider Simplyhealth. Telemetry technology, which ...
(Date:1/15/2014)... NY (PRWEB) January 15, 2014 The Microcompetition ... a major disease. One of these latent viruses is the ... rheumatoid arthritis (RA). Rheumatoid arthritis (RA) is a chronic inflammatory ... theory, a study found that RA patients have high concentrations ...
Breaking Biology Technology:Niagara Thermal Products LLC Selected as Critical Supplier for Buffalo BioBlower Air Purification Systems 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 2Oxford BioTherapeutics Appoints Thomas C Reynolds MD, PhD to its Board of Directors 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 2Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 4Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 2Study: Rheumatoid Arthritis (RA) Patients Have EBV; The CBCD Says this is Consistent with Microcompetition 3
... PharmAthene, Inc.,(Amex: PIP ) a biodefense ... announced that the Delaware Chancery Court,today issued a ... dismiss,PharmAthene,s complaint, which alleges that it has a ... SIGA,s drug candidate, SIGA-246. SIGA,s,request to dismiss the ...
... Helix BioPharma Corp.,(TSX: HBP/Frankfurt: WKN 918846) announced today ... Inc. ("KBI") to develop a process for,preparing L-DOS47 ... clinical testing., "This new arrangement advances the ... with L-DOS47," said John Docherty, Helix,s,president. "The lyophilized ...
... Bristol-Myers Squibb,Company (NYSE: BMY ) will announce ... on Thursday, January 31. During a 10 a.m. (ET) ... information and will,address inquiries from investors and analysts., ... to a live,webcast of the call at http://www.bms.com/ir ...
Cached Biology Technology:Delaware Court Denies Motion by SIGA Technologies Seeking to Dismiss PharmAthene's Legal Action in Breach of Contract Lawsuit Against SIGA 2Helix BioPharma Corp. contracts KBI Biopharma to develop an L-DOS47 clinical packaging format 2Helix BioPharma Corp. contracts KBI Biopharma to develop an L-DOS47 clinical packaging format 3
(Date:4/24/2014)... at Ludwig-Maximilians-Universitaet (LMU) in Munich have identified the ... to discriminate between viral and endogenous RNAs in ... take control of cellular metabolism and hijack cellular ... process is dependent on viral RNA molecules that ... RNA viruses) and/or newly synthesized in the host ...
(Date:4/24/2014)... With a new generation of military veterans returning home ... become a prominent concern in American medical institutions and ... 35 percent of personnel deployed to Iraq and Afghanistan ... South Carolina School of Medicine is shedding light on ... and surprising ways. , The rise in PTSD has ...
(Date:4/23/2014)... pair of bioethics experts have added "playwright" to their ... in grappling with an onslaught of ethical issues as ... the human genome was first sequenced. , Until ... W. Bush have been performed for, and by, their ... conferences, meetings and in classrooms. With Oxford University ...
Breaking Biology News(10 mins):Viral infections: Identifying the tell-tale patterns 2Viral infections: Identifying the tell-tale patterns 3New study links inflammation in those with PTSD to changes in microRNA 2New study links inflammation in those with PTSD to changes in microRNA 3Bioethicists use theatrical narratives to bridge the gap between society and science 2Bioethicists use theatrical narratives to bridge the gap between society and science 3
... For the first time, neuroscientists have systematically identified the ... communications network that supports brain function. Their work, ... in Human Neuroscience , has major implications for understanding ... have the greatest influence over all other connections, the ...
... 10, 2014In a study published today in ... Ken Shepard, professor of electrical engineering and biomedical ... professor of biological sciences at Columbia University, has ... modern computers and communications devices, can be used ...
... Feb. 10, 2014 The Translational Genomics Research Institute (TGen) ... to the brain, according to a first-of-its-kind study published in ... of genetic targets uncovered by TGen now can be used ... therapies for the estimated 45,000 patients in the U.S. each ...
Cached Biology News:How our brain networks: Research reveals white matter 'scaffold' of human brain 2How our brain networks: Research reveals white matter 'scaffold' of human brain 3Chips that listen to bacteria 2TGen study uncovers possible genetic markers in breast cancer that spreads to the brain 2
... the Adept CE 4100 high pressure dual piston ... wavelength detector for added flexibility. The ... and interface unit, CE 4901., The CE 4901 ... be used with Windows 98 and 2000, offers ...
...
... Chromosomal Grade Agarose was developed specifically for pulsed field separations of DNA larger than 2, ... megabase pairs. This ... ... Megabase DNA separations done in Chromosomal Grade, ...
Anti-human VEGFR-2/KDR (Protein-A Purified) Polyclonal Antibody...
Biology Products: