Navigation Links
Charleston Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting on New Migraine Treatment CL-H1T
Date:7/23/2013

CHARLESTON, S.C., July 23, 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 completion of its scheduled Pre-IND meeting with the U.S Food and Drug Administration (FDA) for the proposed Investigational New Drug, CL-H1T, as a novel treatment for patients who suffer from migraine pain and migraine induced nausea or vomiting.   

"The Pre-IND meeting with FDA's Division of Neurology Products (DNP) was positive and productive," said Mr. John Ameling, Vice President of Regulatory Affairs at Charleston. "The questions we raised in the Briefing Document were answered and clarified in the meeting. I am confident that Charleston will be able to conduct the Drug Development Program that DNP agreed to and submit an approvable a 505 (b) (2) New Drug Application."  

"From a drug development standpoint, the information we received from FDA during our Pre-IND meeting will facilitate our ability to complete our proposed program on CL-H1T" said Dr. Bill Kozarek, Charleston's Vice President of Product Development.  "I am very excited to advance the CL-H1T program to demonstrate significant benefits for patients who suffer from migraines, relieving pain and reducing or eliminating 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 Charleston Laboratories, Inc. Request for Pre-IND Meeting on New Migraine Treatment
2. Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial
3. Charleston Laboratories, Inc. beginnt mit klinischer Phase 3-Studie für CL-108
4. Clontech Laboratories, Inc. Partners With Rubicon Genomics To Increase Speed And Efficiency Of Sample Preparation For RNA Sequencing
5. Besins Healthcare, Shin Nippon Biomedical Laboratories, Ltd Announce Delivery Technology Licensing Agreement for Intranasal Progesterone
6. Antigen Laboratories, Inc. to be Acquired by Ares Life Sciences
7. Positive Data, Pipeline Improvements & Market Expansion - Research Report on Abbott Laboratories, Stryker Corporation, St. Jude Medical, Cardiovascular Systems and MAKO Surgical
8. Abuse Deterrent Medicines Developer Pisgah Laboratories, Inc. Wins Top 5 Technologies Award from CLAAD
9. Abuse-Deterrent Medication Developer, Pisgah Laboratories, Achieves Top 5 Technologies Ranking
10. Pisgah Laboratories, Inc. Scores a Triple Play in the World Series Against Prescription Drug Abuse
11. IncellDx, Inc. Announces an Agreement with BioReference Laboratories, Inc. to Conduct a 10,000 Sample Study Using a Slideless Pap Smear
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... InDex Pharmaceuticals Holding AB (publ) today announced ... of the European Crohn,s and Colitis Organisation (ECCO). The ECCO congress ... on inflammatory bowel disease (IBD). The congress is held in ... ... again having been selected to present data at the largest IBD ...
(Date:1/21/2017)... , Jan. 20, 2017 ResMed (NYSE: ... Medical ( Winter Haven, Florida ) today announced they ... parties. BMC and 3B will be permitted to sell their existing ... make a one-time settlement payment to 3B to close the ... did not include an admission of liability or wrongdoing by any ...
(Date:1/21/2017)... 20, 2017 Research and Markets has announced ... Trends - Technology, Route Of Administration, End User - Forecast to ... ... to grow at a CAGR of around 7.8% over the next ... This industry report analyzes the global markets for Advanced Drug Delivery ...
Breaking Medicine Technology:
(Date:1/23/2017)... ... 23, 2017 , ... DMG Productions is proud to announce ... scheduled to broadcast Saturday, January 28, 2017 at 5:00pmEST. , This segment will ... address the limitations of fatigue monitoring technologies within the mining industry. Today SmartCap ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... organization in North America for the scientific development, healthcare training and clinical application ... Session, and its 2017 AAT Member Certification Qualification Courses for Technicians, respectively. , ...
(Date:1/23/2017)... ... January 23, 2017 , ... "ProRandom is a set of camera tools that allow video editors ... Final Cut Pro X," said Christina Austin - CEO of Pixel Film Studios. , ... text with video footage. ProRandom works by using a virtual camera to create the ...
(Date:1/23/2017)... ... January 23, 2017 , ... “Crossing the Bar”: a moving and eloquent ... life. “Crossing the Bar” is the creation of published author, Charlotte Hotte, a North ... who credits the inspiration of the book to her sister, Denise, wishes to acknowledge ...
(Date:1/22/2017)... ... , ... Phytocéane invites clients to take an exotic journey deep into the ... MILKY CREAM. Inspired by the beauty of Zanzibar, a Tanzanian archipelago off the coast ... coral to create this gentle, velvety body cream to envelop the skin in moisture ...
Breaking Medicine News(10 mins):