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

   

Abuse-Deterrent Opioid From Neura Therapeutik Complies With FDA Draft Guidance


1/15/2013 10:06:52 AM

PRINCETON, N.J., Jan. 15, 2013 /PRNewswire/ -- Neura Therapeutik announced today the securing of terms on NL-001, an abuse-deterrent, long-acting opioid analgesic and that studies conducted on NL-001 comply with recent FDA draft guidance. Issued last week, this guidance is intended to assist pharmaceutical companies who wish to develop abuse deterrent opioid formulations.

Prescription opioids are a mainstay in the management of moderate-to-severe chronic pain. However abuse and misuse of these medications have led to a serious public health crisis. Abusers of long-acting opioids seek to defeat the time-release properties of these medications to achieve immediate euphoria. Many long-acting opioids' time-release properties can be defeated by crushing and then ingesting, crushing and then snorting, injecting intravenously after extraction from a tablet or capsule or co-ingesting with alcohol. Opioids with a reduced abuse liability are the most important unmet need in the development of new long-acting opioids for chronic pain. Commenting on the abuse crisis, Jeff Gudin, MD, Director Pain and Palliative Care, Englewood Hospital and Medical Center in New Jersey, said, "Achieving a balance between pain control and minimizing the risks of abuse, misuse and diversion is critical to foster better treatment outcomes."

Neura Therapeutik will be completing final pharmacokinetic studies for NL-001, a proprietary abuse-deterrent version of a long-acting opioid. Studies conducted to date demonstrate that Neura's product is less susceptible to manipulation and conforms to FDA's draft guidance. It has physical barriers that prevent chewing, crushing, grating or grinding. Its chemical barriers resist extraction of the opioid using common household solvents or co-ingesting with alcohol. In addition, its key differentiating feature compared to other abuse-deterrent formulations is its ability to retain its extended-release properties even when crushed.

"We commend the FDA for issuing this draft guidance in its efforts to address this serious public health issue," said John La Lota, CEO of Neura Therapeutik. "NL-001 coupled with a comprehensive educational and risk management program would be integral to providing patients with adequate pain management, while attempting to minimize the abuse, misuse and diversion of opioids within the community."

NL-001 is the first in Neura's abuse-deterrent opioid portfolio and is being developed for the U.S. market. NL-001 is expected to be launched in early 2015. Neura is seeking strategic partnerships to advance these products in the US and globally.

About Neura Therapeutik:

Neura Therapeutik LLC (Neura) is a pain specialty company focused on the commercialization of innovative analgesics that address unmet needs in the marketplace. Neura is divided into two strategic business units:

  • Neura Labs, LLC Focused on the in-licensing and launch of pharmaceutical assets where Neura's development and commercial experience can be leveraged to provide value enrichment through optimal clinical development and commercial advancement.
  • Neura Group, LLC Focused on providing an array of commercial services and management oversight that will optimize the value of market ready/currently marketed assets.

Please visit neuratherapeutik.com for more information.

Media Contact: Greg Gironda
Neura Therapeutik LLC
609-256-1942
girondag@neuratherapeutik.com

This press release was issued through eReleasesĀ® Press Release Distribution. For more information, visit http://www.ereleases.com.

SOURCE Neura Therapeutik LLC



Read at BioSpace.com

   

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