BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Accepts For Review Purdue Pharma L.P.'s New Drug Application For Targiniq™ ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII


11/26/2013 8:49:24 AM

free biotech news Get the latest biotech news where you want it. Sign up for the free GenePool newsletter today!

Stamford, CT – November 26, 2013 – Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Targiniq™ ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain.

“This milestone brings us closer to offering an important treatment option for the management of chronic pain,” said Gary L. Stiles, MD, Purdue Pharma’s Senior Vice President of Research and Development. “It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features.”

This investigational drug combines the opioid analgesic, oxycodone, and the opioid antagonist, naloxone. If approved by the FDA, Targiniq ER would be available in 10/5 mg, 20/10 mg and 40/20 mg dosage strengths for dosing every 12 hours (Q12H).

The NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies designed and conducted consistent with FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. In the NDA submission, Purdue Pharma is requesting the inclusion of language about abuse deterrence in the product’s proposed label based on the results of these studies.

This product was first approved in Germany in 2006 under the brand name Targin® and is currently marketed in 32 countries, including Canada, the United Kingdom, and Australia under the trade names Targin®, Targiniq®, and Targinact®.

About Chronic Pain

Purdue is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and costs the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity.1

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products.

Additional information about Purdue can be found at www.purduepharma.com.

Contact:

James Heins Senior Director, Public Affairs Office: 203-588-8069 Email: james.heins@pharma.com

Help employers find you! Check out all the jobs and post your resume.


Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES