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:7/24/2014)... DUBLIN , July 24, 2014 ... the "Global Cell Culture Market 2014-2018" report ... Cell culture is the in vitro ... such as research, cell studies, and biopharmaceutical production. Cell ... vaccine production. Cell culture instruments and cell culture consumables ...
(Date:7/24/2014)... Your cell phone may stay charged ... storage capacity. , New research indicates that lithium-ion ... at Lawrence Livermore National Laboratory and ... components will perform as electrodes. , The growing ... for higher-performance batteries. Several key characteristics of lithium-ion ...
(Date:7/24/2014)...  CorMedix Inc. (NYSE MKT: CRMD), a pharmaceutical ... for the prevention and treatment of cardiorenal and ... July 18, 2014 from the NYSE MKT LLC ... plan to regain compliance with continued listing standards ... is continuing the Company,s listing and has granted ...
(Date:7/24/2014)... 2014 2014 Deep Research Report ... a professional and in-depth research report on Potassium ... basic information, including its definition, classification, application, ... research covers the international market analysis, including China’s ... covering macroeconomic environment & economic situation analysis, the ...
Breaking Biology Technology:Global Cell Culture Market 2014-2018: Key Vendors are Becton, Dickinson and Co, EMD, GE Healthcare, Lonza Group, Sigma Aldrich and Thermo Fisher Scientific 2Getting More Life out of Lithium-ion Batteries 2CorMedix, Inc. Granted Extension of NYSE-MKT Listing 2CorMedix, Inc. Granted Extension of NYSE-MKT Listing 3Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 2Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 3Potassium Sulphate Market & SHMP Industry 2014 (Global, China) Analysis Now Available at DeepResearchReports.com 4
... , , ROCKVILLE, Md., ... has announced that 263 regulatory professionals achieved Regulatory Affairs ... RAC credential is administered by RAPS and is the ... product sector. , , (Logo: ...
... BEIJING, Sept. 4 /PRNewswire-Asia/ -- ... provider of biopharmaceutical products in China, announced today that,the ... Republic,of China has issued the initial order to Sinovac ... to the initial order, Sinovac is,required to complete the ...
... September 4 Karolinska Development (publ),today announced that one ... clinical study of its candidate drug, tafoxiparin, a,new drug ... promising results of the Phase II trial bring the ... strategy. , Dilafor,s candidate drug, ...
Cached Biology Technology:263 Regulatory Professionals Achieve RAC Certification 2263 Regulatory Professionals Achieve RAC Certification 3Sinovac Obtains Initial Order of H1N1 Vaccine from Chinese Central Government 2Sinovac Obtains Initial Order of H1N1 Vaccine from Chinese Central Government 3Karolinska Development Portfolio Company Completes Successful Phase II Clinical Trial 2Karolinska Development Portfolio Company Completes Successful Phase II Clinical Trial 3
(Date:7/24/2014)... 2014) Scientists at The New York Stem ... closer to creating a viable cell replacement therapy ... , For the first time, NYSCF scientists ... skin samples of patients with primary progressive multiple ... to induce these stem cells into becoming oligodendrocytes, ...
(Date:7/24/2014)... York, NY - July 24, 2014 -- Keryx Biopharmaceuticals, ... from the long-term, randomized, active control Phase 3 study ... iron-based phosphate binder, for the treatment of hyperphosphatemia in ... PERFECTED study (PhosphatE binding and iRon delivery with FErric ... Journal of the American Society of Nephrology ...
(Date:7/24/2014)... YORK, NY (July 24, 2014) Scientists at ... Institute are one step closer to creating a ... a patient,s own cells. , For the ... (iPS) cells lines from skin samples of patients ... developed an accelerated protocol to induce these stem ...
Breaking Biology News(10 mins):NYSCF scientists one step closer to cell therapy for multiple sclerosis patients 2Zerenex™ (ferric citrate) long-term Phase 3 study results published in JASN 2Zerenex™ (ferric citrate) long-term Phase 3 study results published in JASN 3Zerenex™ (ferric citrate) long-term Phase 3 study results published in JASN 4NYSCF scientists 1 step closer to cell therapy for multiple sclerosis patients 2
... Hopkins scientists seems to have discovered an almost-too-easy way to ... potent versions. Their finding, reported this week in Nature, could ... but also other body tissues. What the researchers ... neural stem cells the sort that might be used ...
... The giant panda is not at an evolutionary dead end ... new research involving scientists from Cardiff University. Previous ... requirements and slow reproductive rates have led to a lack ... extinction. Now a study by Professor Michael Bruford ...
... August 23, 2007 On August 16, the Food and ... sold under the brand name Coumadin. The new label suggests ... be safer for patients with variations in two genes, CYP2C9 ... testing, which may be a useful tool in determining appropriate ...
Cached Biology News:When is a stem cell not really a stem cell? 2American College of Medical Genetics responds to new FDA labeling decision for warfarin 2
Request Info...
supplied with 10x reaction buffer...
... from yeast/leuconostoc overproducer ATP: ... EC 2.7.1.1/1.1.1.49. One unit of ... of D-glucose in 1 min ... One unit of G6P-DH will ...
Request Info...
Biology Products: