Navigation Links
Supplemental New Drug Application Submitted to FDA for NUCYNTA® ER (Tapentadol) Extended-Release Tablets for Diabetic Peripheral Neuropathic Pain
Date:10/31/2011

TITUSVILLE, N.J., Oct. 31, 2011 /PRNewswire/ -- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NUCYNTA® ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults. The FDA approved NUCYNTA® ER on August 25, 2011, 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.

In the United States, there are nearly 26 million people living with diabetes and, over time, they can develop a type of nerve damage called neuropathy. Approximately 60 to 70 percent of people with diabetes have some form of neuropathy. The most common type is DPN, which causes pain or loss of feeling in the toes, feet, legs, hands, and arms. It is estimated that painful DPN affects 10 to 20 percent of all patients with diabetes, and many patients on current treatments still experience considerable pain.

The submission is based on a full clinical development program, including Phase 3 double-blind, randomized, active-and placebo-controlled studies. These clinical trials explored the efficacy and safety of NUCYNTA® ER for the management of neuropathic pain associated with DPN in adults.  

Data from these studies provide evidence that NUCYNTA® ER has efficacy to reduce diabetic peripheral neuropathic pain compared to placebo. The data also provide evidence of long-term safety and tolerability of NUCYNTA® ER.

J&JPRD is conducting the clinical program for NUCYNTA® ER in the United States. J&JPRD submitted the sNDA on behalf of Janssen
'/>"/>

SOURCE Janssen Pharmaceuticals Research & Development
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11 12 13

Related medicine technology :

1. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
2. ORENCIA(R) (abatacept) Supplemental Biologics License Application for Juvenile Idiopathic Arthritis Accepted by FDA for Filing and Review
3. FDA Accepts Wyeths Supplemental New Drug Application for Tygacil for the Treatment of Patients with Community-Acquired Pneumonia
4. Supplemental New Drug Application for PREZISTA(TM) Submitted to U.S. Food and Drug Administration
5. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
6. CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
7. Anesiva Announces FDA Approval of Supplemental New Drug Application to Expand Zingo(TM) Indication
8. FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)
9. Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder
10. Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA
11. Cephalon Announces that FDA Grants Priority Review of its Supplemental New Drug Application for NUVIGIL as a Treatment for Excessive Sleepiness Associated with Jet Lag Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... , Sept. 19, 2014 /PRNewswire-iReach/ -- ... Oxybutynin Hydrochloride Industry, 2009-2019 is a professional ... Chinese Oxybutynin Hydrochloride industry. The report firstly ... including its classification, application and manufacturing technology. ... top manufacturers of Oxybutynin Hydrochloride listing their ...
(Date:9/19/2014)... , Sept. 19, 2014 /PRNewswire-iReach/ -- ... to 2020″, provides key market data ... devices market. The report provides value, ... volume (in units) within market categories ... Sigmoidoscopes, Esophagoscopes & Gastroscopes, Duodenoscopes, Laparoscopes, ...
(Date:9/19/2014)... 2014 Kiromic, LLC, a Lubbock ... Hance , the former chancellor of Texas Tech University, to ... in July 2014, after raising $1.2 billion for the university. ... Hance , the most successful chancellor in the history of ... as an investor, but also as our new vice chairman ...
Breaking Medicine Technology:Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 2Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 3Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 4Oxybutynin Hydrochloride Industry 2014-2019 Chinese Forecasts & Analysis 5United States General Surgery Devices Market to 2020 - Endoscopy, Bariatric Surgery, Aesthetic Lasers and Energy, Biopsy Devices, Hernia Repair, Non-Vascular Stents 2United States General Surgery Devices Market to 2020 - Endoscopy, Bariatric Surgery, Aesthetic Lasers and Energy, Biopsy Devices, Hernia Repair, Non-Vascular Stents 3United States General Surgery Devices Market to 2020 - Endoscopy, Bariatric Surgery, Aesthetic Lasers and Energy, Biopsy Devices, Hernia Repair, Non-Vascular Stents 4United States General Surgery Devices Market to 2020 - Endoscopy, Bariatric Surgery, Aesthetic Lasers and Energy, Biopsy Devices, Hernia Repair, Non-Vascular Stents 5Former Texas Tech Chancellor Named New Vice Chairman of the Board of Kiromic, LLC 2
(Date:9/20/2014)... September 20, 2014 Ticket Down ... tickets . This popular ticket exchange is offering their ... , The 2015 schedule of tours is beginning to fill ... announced their plans to hit the road, including 21-year-old pop ... announced the “Honeymoon Tour,” which will take her to 25 ...
(Date:9/20/2014)... 20, 2014 Lifeinsurancequoteterm.net has released ... no medical exam life insurance plan provides for vulnerable ... family members should be a top priority for every ... insurance without taking medical examinations and visiting a doctor. ... medical examinations will provide coverage up to $300,000, but ...
(Date:9/20/2014)... 2014 New PharmaPoint Drug Evaluation ... to 2023?. The asthma market saw very slow ... become saturated with relatively efficacious standard therapies, such ... corticosteroids and long-acting beta-agonists (ICS/LABAs), and leukotriene modifiers, ... However, the launch of seven novel targeted biologic ...
(Date:9/20/2014)... September 20, 2014 Traditionally dentists have advised ... South Charlotte Dentistry is re-visiting that advice and ... effects that coffee and wine have on oral health. “There’s ... determined that coffee may be beneficial in protecting against gum ... , The study on coffee was from the September ...
(Date:9/20/2014)... September 20, 2014 QueenBeeTickets.com is ready ... star’s tour performances. She will visit many cities in ... until the 16th of April. , Click Here ... Tour tickets at QueenBeeTickets.com. , The star’s fans are ... see their favorite young singer in a live performance. ...
Breaking Medicine News(10 mins):Health News:Ariana Grande Tickets in Phoenix, Los Angeles, Anaheim, San Jose, Seattle, and Vancouver Go on Sale Today 2Health News:Ariana Grande Tickets in Phoenix, Los Angeles, Anaheim, San Jose, Seattle, and Vancouver Go on Sale Today 3Health News:No Medical Exam Life Insurance Provides Financial Protection for Families 2Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 2Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 3Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 4Health News:South Charlotte Dentist, Dr. James Wells, is Changing His Advice on Coffee and Wine Drinking 2Health News:South Charlotte Dentist, Dr. James Wells, is Changing His Advice on Coffee and Wine Drinking 3Health News:Discount Ariana Grande Tickets: QueenBeeTickets.com Delights Fans with Discount Concert Tickets for Ariana Grande’s 2015 Honeymoon Tour 2
... Japan, May 8 Dr. Hidenari Tanaka, president ... of the Japan Contact Lens Association, was appointed ... the government of the Republic of Singapore. The ... Consulate-General will be located at Menicon,s corporate headquarters ...
... HealthSystem Consortium (UHC) today announced that it has awarded ... in Gaithersburg, Md, for food and nutrition services. The ... effective on May 1, 2009. Sodexo is a leading ... services to hospital patients, staff, and visitors. Services are ...
... Reform Work for ChildrenSTANFORD, Calif., May 7 Lucile ... the National Association of Children,s Hospitals (N.A.C.H.) as it ... Congress and the Obama Administration to make health care ... extraordinarily proud to be taking part in Speak Now ...
... Inc., (Nasdaq: MEDQ ) a leading provider of ... workflow, today announced its unaudited operating results for its first ... of 2009 was $6.9 million, an increase of $11.3 million ... $4.4 million was reported. Earnings per share for the first ...
... Va., May 7 Trey Anastasio, lead singer of the ... Hill on Wednesday, May 6, to participate in a day-long ... joined the National Association of Drug Court Professionals (NADCP) in ... in need. Mr. Anastasio recognized over fifteen members of Congress ...
... is a statement from Georges C. Benjamin, MD, FACP, ... Association:"The American Public Health Association (APHA) joins other leading ... in President Obama,s FY 2010 budget."Of particular note is ... be used to finance health reform and ensure that ...
Cached Medicine News:Health News:Dr. Tanaka Appointed as Honorary Consul-General by Republic of Singapore 2Health News:University HealthSystem Consortium Selects Sodexo to Provide Food and Nutrition Services 2Health News:Lucile Packard Children's Hospital at Stanford to Raise Its Voice for Kids in Health Care Reform Debate 2Health News:Lucile Packard Children's Hospital at Stanford to Raise Its Voice for Kids in Health Care Reform Debate 3Health News:MedQuist Reports First Quarter 2009 Results 2Health News:MedQuist Reports First Quarter 2009 Results 3Health News:MedQuist Reports First Quarter 2009 Results 4Health News:MedQuist Reports First Quarter 2009 Results 5Health News:MedQuist Reports First Quarter 2009 Results 6Health News:MedQuist Reports First Quarter 2009 Results 7Health News:MedQuist Reports First Quarter 2009 Results 8Health News:MedQuist Reports First Quarter 2009 Results 9Health News:Phish Frontman Trey Anastasio Visits Capitol Hill to Support Drug Courts and Calls on Congress to Put a Drug Court Within Reach of Every American in Need 2Health News:Phish Frontman Trey Anastasio Visits Capitol Hill to Support Drug Courts and Calls on Congress to Put a Drug Court Within Reach of Every American in Need 3Health News:APHA Applauds Health Reform Fund and Other Health Investments in Budget 2
Serrated handle with 7 mm tying platform and polished finish. Teeth: 0.25 mm, 2 x 2 set at 45 degrees....
5 mm tying platform, serrated cross action handle with polished finish. Teeth: 0.10 mm, 1 x 2 set at 90 degrees....
5 mm tying platform, serrated cross action handle with polished finish. Teeth: 0.10 mm, 1 x 2 set at 45 degrees....
6 mm tying platform. Round knurled handle with polished finish. Teeth: 0.3 mm, 1 x 2. Orientation: Left hand....
Medicine Products: