Navigation Links
FDA Grants Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
Date:4/16/2013

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.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Chimerix Fast Track Designation for CMX001 for the Prevention of Clinically Significant Cytomegalovirus Infection
2. Pancreatic Cancer Action Network Opposes Sequestration Cuts To National Institutes Of Health & Cancer Research Grants
3. State Food and Drug Administration Grants Approval to Sihuan Pharmaceutical for Clinical Trial of Innovative Drug -- Pinoxacin Hydrochloride
4. Neuralstem Grants Licenses For Central Nervous System Therapy Surgical Devices To Cedars-Sinai Medical Center
5. FDA Grants Orphan Drug Status To Eisais Lenvatinib
6. FDA Grants 510(k) clearance for new Fluke Biomedical ESA615 Electrical Safety Analyzer
7. U.S. FDA Grants Priority Review to Bayers Radium Ra 223 Dichloride NDA for Castration-Resistant Prostate Cancer with Bone Metastases
8. Afraxis Grants Exclusive Global License to Genentech
9. FDA Grants Soligenix Fast Track Designation for OrbeShield(TM) for the Reduction of Mortality Associated with Gastrointestinal Acute Radiation Syndrome (GI ARS)
10. New Jersey Health Foundation Awards First Two Innovation Stage Funding Grants
11. Artemis Diagnostics awarded two grants from Technology Strategy Board to develop cancer imaging technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ANDOVER, Mass. and SAN CLEMENTE, Calif. ... California -based mobile pulmonary function testing company, is now ... portable PFT devices developed by ndd Medical Technologies , Inc. ... PFT testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ... CA , can get any needed testing done in the ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal ... personalized through a fitness app. The fitness app plans to fix the two major problems ... offer a one size fits all type program , They don’t eliminate all ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand ... project," said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s ... within Final Cut Pro X . Simply select a ProHand generator and drag ...
(Date:6/25/2016)... ... 25, 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s ... setting the bar too high can result in disappointment, perhaps even self-loathing. However, those ... goal. , Research from PsychTests.com reveals that behind the tendency to ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... TX (PRWEB) , ... June 24, 2016 , ... People ... part in Genome magazine’s Code Talker Award, an essay contest in which patients and ... an award to be presented at the 2016 National Society of Genetic Counselors (NSGC) ...
Breaking Medicine News(10 mins):