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 Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment


4/16/2013 10:56:42 AM

CHARLESTON, S.C., April 16, 2013 /PRNewswire/ -- Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting related to opioid analgesics and other pain associated disease states, announced today the U.S. Food and Drug Administration has granted its request for a Pre-IND meeting to discuss the proposed Investigational New Drug, CL-H1T, as a novel treatment for patients who suffer from migraine pain and migraine induced nausea or vomiting.

"Charleston is very pleased with the response from the Neurology Products Division at FDA," said Mr. John Ameling, Vice President of Regulatory Affairs at Charleston. "This meeting is a positive step towards the development of our novel migraine product, CL-H1T. We look forward to discussing our proposed drug development program with FDA and initiating our clinical trials towards an approvable New Drug Application (NDA)."

"Our meeting with the agency in July is an important step in our development of CL-H1T," said Mr. Ryan Baker, Executive Vice President and Chief Operating Officer at Charleston Labs. "After our meeting with FDA, we will be looking to enter into the best strategic partnership to successfully complete the clinical trials and support commercialization for CL-H1T to help the millions of patients suffering from migraine headaches and migraine induced nausea or vomiting."

"This milestone marks the second investigational drug in Charleston's pipeline to reach the clinic," Mr. Paul Bosse, President and Chief Executive Officer, commented. "In addition to CL-108, which is in Phase 3 development for the treatment of acute moderate to severe pain, the development of this migraine drug signals our company's range of pharmaceuticals for different types of pain associated with nausea and vomiting."

About Charleston Laboratories, Inc.

Charleston Laboratories, Inc is a specialty pharmaceutical company focused on the research and development of novel pain products that prevent or significantly reduce nausea and vomiting, the two most burdensome side effects related to opioid analgesics and other pain associated disease states. Charleston's new products will address Opioid Induced Nausea and Vomiting (OINV), Postoperative Nausea and Vomiting (PONV), Chemotherapy Induced Nausea and Vomiting (CINV), Radiation Induced Nausea and Vomiting (RINV), and Migraine Induced Nausea and Vomiting (MINV). In addition, Charleston is developing other products without acetaminophen to reduce the potential for liver injury and formulations with abuse deterrent technologies designed to curb misuse and abuse. Charleston Laboratories intends to enter into discovery and commercialization alliances with partners motivated to introduce novel pain therapies that eliminate or significantly reduce nausea and vomiting.

www.charlestonlabs.com.

SOURCE Charleston Laboratories, Inc.



Read at BioSpace.com

   

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