Navigation Links
Charleston Laboratories, Inc. Begins Enrollment for CL-108 Phase 3 Clinical Trial
Date:1/28/2013

CHARLESTON, S.C., Jan. 28, 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 that patient enrollment has begun for the company's pivotal Phase 3 clinical trial for its first product, CL-108, for the treatment of moderate to severe pain.

"The initiation of this study marks the culmination of work by many people," said Dr. Bernard P. Schachtel , Chief Scientific Officer of Charleston.  "In addition to input by our scientific, clinical and regulatory advisors, the investigators at the research centers where this study is being conducted also contributed to the protocol."  Dr. Schachtel noted in particular the advice of Dr. Elliot V. Hersh , Professor of Oral & Maxillofacial Surgery and Pharmacology at the University of Pennsylvania, where Dr. Hersh is Principal Investigator for the trial.  "As exemplified by the enthusiasm and dedication of the many doctors, nurses, study coordinators, and other researchers at our recent Investigators Meeting," Dr. Schachtel continued, "this study offers the rare and exciting opportunity to research a truly novel indication, the treatment of both moderate to severe pain and the nausea and vomiting commonly associated with its treatment."  

"This day represents a major milestone for Charleston in our quest to develop differentiated and innovative pain products," said Paul Bosse , President and Chief Executive Officer of Charleston.  "I am proud of the Charleston team, specifically the critical roles they played in drug manufacturing, regulatory affairs and project management, and Dr. Schachtel's team of world-renowned scientific advisors and clinical investigators, including the new study instruments which Dr. Schachtel developed for the measurement of nausea.  CL-108 is unique," Mr. Bosse added, "in that it will be the only commercial product that combines an anti-emetic with an opioid to treat moderate to severe pain while significantly reducing and in many cases eliminating opioid induced nausea and vomiting (OINV).  Nausea and vomiting are the most common and burdensome side effects of opioid medications and have a significant impact on patients' lives and the physicians treating these patients.  Demonstrating the many values of an opioid medication with less OINV in this Phase 3 study will not only advance the entry of CL-108 into the marketplace but further our development of other Charleston products now in the lab.  With our extensive pipeline, Charleston intends to produce different medicines for patients in pain without the distressing symptoms of nausea and vomiting caused by currently available strong analgesics."     

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. Charleston Laboratories, Inc. beginnt mit klinischer Phase 3-Studie für CL-108
2. Everett Laboratories, Inc. Files Patent Infringement Lawsuit Against Competitor Trigen Laboratories, Inc.
3. IncellDx, Inc. Announces an Agreement with BioReference Laboratories, Inc. to Conduct a 10,000 Sample Study Using a Slideless Pap Smear
4. Pisgah Laboratories, Inc. Scores a Triple Play in the World Series Against Prescription Drug Abuse
5. Abuse-Deterrent Medication Developer, Pisgah Laboratories, Achieves Top 5 Technologies Ranking
6. Abuse Deterrent Medicines Developer Pisgah Laboratories, Inc. Wins Top 5 Technologies Award from CLAAD
7. SuccessEHS "Forward Together" Customer Conference Begins
8. Medical Alarm Begins Revenue Recognition from Largest Set of Orders -- Releases New Television Commercial
9. Insmed Incorporated Begins Screening Patients For TARGET-NTM U.S. Clinical Trial Of ARIKACE® In Patients With Non-tuberculous Mycobacterial Lung Disease
10. Siteman Cancer Center at Barnes-Jewish and Washington University Begins Imaging with First ViewRay System
11. Countdown Begins For AdvaMed 2012: The Medtech Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/11/2017)... Texas , Oct. 11, 2017  Caris Life ... focused on fulfilling the promise of precision medicine, today ... has joined Caris, Precision Oncology Alliance™ (POA) as its ... cancer centers, the St. Jude Crosson Cancer Institute will ... advance the use of tumor profiling, making cancer treatment ...
(Date:10/7/2017)...   Provista, a proven leader in the ... purchasing power, today announced a new resource area on ... is the online home for case studies, articles ... news releases, slideshows and events. ... resources at their fingertips, viewers can also watch short ...
(Date:10/2/2017)... , Oct. 2, 2017 Diplomat Pharmacy, ... 8th Day Software and Consulting, LLC , and named ... 8th Day Software, based in Tennessee , ... 8th Day expands EnvoyHealth,s service offerings for health care ... "In an interoperable ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... meet the demand of today’s consumer and regulatory authorities worldwide. From Children’s to ... and tested to meet the highest standard. , These products are also: ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
Breaking Medicine News(10 mins):