Navigation Links
Phase 3 Data Show NUCYNTA® ER (tapentadol) Extended-Release Tablets Provide Pain Management for Patients with Diabetic Peripheral Neuropathy (DPN)
Date:5/17/2012

tudy design, please visit www.clinicaltrials.gov (NCT01041859).

Janssen Research & Development, LLC  and Grunenthal GmbH, conducted this study, which Janssen Research & Development, LLC has included as part of its Supplemental New Drug Application (sNDA) submitted on October 28, 2011 to the U.S. Food and Drug Administration (FDA) for tapentadol ER tablets for the management of neuropathic pain associated with DPN in patients 18 years of age or older. The FDA currently is reviewing this supplemental application.

About Tapentadol and NUCYNTA® ER

Tapentadol is a centrally-acting synthetic analgesic. The tapentadol molecule is classified as Schedule II of the Controlled Substances Act.

NUCYNTA® ER (tapentadol) extended-release tablets are an oral analgesic available by prescription only and indicated for the management of moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. NUCYNTA® ER is taken twice daily and available in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths.

Outside the United States, tapentadol is marketed by Janssen Inc. in Canada; Grünenthal GmbH discovered tapentadol and markets immediate- and extended-release formulations of tapentadol (PALEXIA®) in various countries in Europe.

IMPORTANT SAFETY INFORMATION FOR NUCYNTA® ER (tapentadol) extended-release tablets

WARNING: POTENTIAL FOR ABUSE, PROPER PATIENT SELECTION, AND LIMITATIONS OF USE

Potential for Abuse

NUCYNTA® ER contains tapentadol, a mu-opioid agonist and a Schedule II controlled substance with an abus
'/>"/>

SOURCE Janssen Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12

Related medicine technology :

1. NVA237 Phase III GLOW2 Data at American Thoracic Society (ATS) International Conference and Phase II Clinical Trial Update
2. Boehringer Ingelheim to present pivotal Phase III results for afatinib in first-line treatment of EGFR mutation-positive NSCLC at ASCO 2012
3. Inovio Pharmaceuticals Universal Avian Flu Vaccine Generates Protective Antibody Responses Against Six H5N1 Viruses in Phase I Trial
4. Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer-Targeted Molecular Radiotherapeutic
5. Adamas Pharmaceuticals Announces Successful End-of-Phase 2 Meeting with FDA for Arimenda™
6. Pearl Therapeutics Phase 2b Twice-Daily Dosing Data Suggest Morning and Evening Benefit of PT003 in Patients with COPD
7. Results Reported for Phase Ib Open-Label Clinical Trial for the Treatment of Depression Using External Trigeminal Nerve Stimulation (eTNS™) - The USB Port to the Brain™
8. Alder BioPharmaceuticals Inc. Initiates Phase 1 Clinical Study of Antibody Therapeutic Candidate for Treatment of Migraine, ALD403
9. Isis Initiates Phase 2 Study of ISIS-APOCIIIRx in Patients with Hypertriglyceridemia
10. Lexicon Receives Funding for Phase 2 Clinical Trial of LX4211 in Type 1 Diabetes
11. Ultragenyx Announces Phase 1 Results of UX001 in Hereditary Inclusion Body Myopathy (HIBM), a Rare Neuromuscular Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/27/2015)... Aug. 27, 2015  The Academy of Managed ... Drug Administration,s (FDA,s) draft guidance and proposed rule ... biosimilars, to bear a nonproprietary name with an ... seeking a decision from the FDA on the ... care stakeholders urging the agency to use the ...
(Date:8/27/2015)... Aug. 27, 2015 DURECT Corporation (Nasdaq: ... present at three upcoming healthcare conferences.  ... will present at the Rodman & Renshaw Investment Conference ... The conference is being held at the St. Regis ... A live audio webcast of the presentation will be ...
(Date:8/27/2015)... ieCrowd™ today announced the achievement of ... the company,s supplemental oxygen delivery device, Smart Oxygen ... by ieCrowd,s subsidiary Smart Oxygen Solutions TM , ... oxygen based on level of activity.  The FDA ... Smart Oxygen device would require a series of ...
Breaking Medicine Technology:AMCP Is Disappointed in FDA's Draft Guidance and Proposed Rule Calling for Suffix on Nonproprietary Names of Biological Products 2DURECT to Participate in Upcoming Healthcare Conferences 2Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 2Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 3Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 4
... Dr. Marisa Weiss, president and founder of Breastcancer.org and ... letter to the U.S. Food and Drug Administration prior ... review data for Avastin,s use in metastatic HER2-negative breast ... has recommended removing Avastin,s approval to treat breast cancer, ...
... reimbursement rates for home medical equipment and services (HME) ... as a result of Medicare,s bidding program going into ... largest metropolitan areas in the U.S. ... City, Miami, Orlando, Pittsburgh, and Riverside, California. The bidding ...
Cached Medicine Technology:Non-Profit Breastcancer.org Shares Concerns with FDA on Avastin Breast Cancer Recommendation 2Non-Profit Breastcancer.org Shares Concerns with FDA on Avastin Breast Cancer Recommendation 3Problems Emerge in Competitive Bidding Pricing Scheme for Home Medical Equipment; Economists Predict the Program Will Fail 2Problems Emerge in Competitive Bidding Pricing Scheme for Home Medical Equipment; Economists Predict the Program Will Fail 3
(Date:8/28/2015)... ... ... “ Frequentz ” was featured on NewsWatch as part of its monthly AppWatch, ... iOS, Android, and Windows. Joe Toohey, the host of AppWatch and technology expert, conducted ... product movement from beginning to end. , Businesses benefit greatly from having the ability ...
(Date:8/28/2015)... ... August 28, 2015 , ... Drugs ... Dr. James Strawbridge, gives a new approach on solutions in his new book ... the employer and employees getting together for meaningful group meetings. "This would educate ...
(Date:8/28/2015)... ... 2015 , ... The Nashville Business Journal recently announced its ... Mr. Troy Mizell, Chairman of the Board at MyGenetx, is one of ... Awards will recognize Nashville military veterans who, through their professional and personal efforts, ...
(Date:8/28/2015)... ... August 28, 2015 , ... Dr. Gregory K. Toumayan, D.C., Q.M.E., is ... in shoulder pain, hip pain, neck pain, stiffness, muscle spasms, and numbness. ... University of Illinois, and then went on to earn his title of Doctor of ...
(Date:8/28/2015)... ... 28, 2015 , ... The Quatela Center for Plastic Surgery is excited to ... nonsurgical product approved by the Food and Drug Administration to eliminate submental fat, also ... William Koenig are among the premier cosmetic surgeons in Rochester to offer this ...
Breaking Medicine News(10 mins):Health News:Track Product Movement from Beginning to End with Frequentz 2Health News:MyGenetx Board Member Receives Veterans Award 2Health News:Healthpointe Welcomes Dr. Gregory K. Toumayan, Chiropractor, to Colton, Temecula, and Perris 2Health News:Healthpointe Welcomes Dr. Gregory K. Toumayan, Chiropractor, to Colton, Temecula, and Perris 3Health News:Non-surgical Treatment to Get Rid of The "Double Chin," Kybella™, Now Available at the Quatela Center for Plastic Surgery 2Health News:Non-surgical Treatment to Get Rid of The "Double Chin," Kybella™, Now Available at the Quatela Center for Plastic Surgery 3
... that the absence of a certain protein interferes with ... the New England journal of medicine,it provides insight ... The protein aquaporin-1has a definitive role in the normal ... study.The study showed that individuals who have a deficiency ...
... usage of antidepressants rather going to psychotherapy among most foreigners. ... depression changed from 1985 to 1999. // ,The rate ... persons to 2.5 per 100 over this time.The proportion of ... cent to 70 per cent - probably due to the ...
... The third man to receive an experimental artificial heart ... the device.// Bobby Harrison appeared at a news conference ... Heart Institute, where he underwent surgery on September 26, ... battery-powered plastic-and-titanium device that's completely implanted into the patient. ...
... 20 years, scientists have laboured under the assumption that ... form its structure and carry out its activities. However, ... influenza virus protein.This protein may kill immune system cells ... potency, the researchers say.// ,The scientists turned up ...
... Too much vitamin A may increase the risk of hip ... things as healthy skin and hair and bone growth.// Researchers ... from food and vitamin supplements - had double the risk ... ,One theory is that too much vitamin A ...
... Stiff person syndrome (SPS) causes the muscles in the limbs ... highly effective treatment for a disorder of the nervous system ... the condition are often too disabled to walk or move, ... suffer a spasm and fall. The condition resembles chronic tetanus. ...
Cached Medicine News: