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:7/31/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO), has been named one of ... by Crain,s Detroit Business . The annual Crain,s ... revenue growth. This year,s edition measures growth from 2013 to ... complete list, visit crainsdetroit.com/awards/fast_50/2017 .  "Being ... Phil Hagerman , CEO and chairman of Diplomat. "We,ve ...
(Date:7/27/2017)... 27, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... June 30, 2017.  The Company reported second quarter net ... the prior year period, and an increase of 2.1% ... points of contribution from the LDR Holding Corporation acquisition, ... quarter of 2016, or 0.3% on a constant currency ...
(Date:7/26/2017)... The Galien Foundation announced today the ... Award Nominees. Counted among the global health innovation ... biomedical and technology product achievement that improves the human condition. ... candidate must be U.S. Food and Drug Administration (FDA) approved ... potential to impact human health. Sales data are not considered ...
Breaking Medicine Technology:
(Date:8/16/2017)... ... ... August 3rd article on Reuters covers a new University of Michigan study on ... of the American Medical Association). The study found that a lower percentage of patients with ... to patients with lower BMIs. At present, weight loss patients must have a BMI of ...
(Date:8/16/2017)... Va. (PRWEB) , ... August 16, 2017 , ... ... America (BIAA) is collaborating with a New England student to educate the public ... to acclaim in 2016 for launching the first-ever National Concussion Awareness Day. , ...
(Date:8/16/2017)... ... , ... Maury Regional Health has announced a large-scale adoption of AccuVein vein ... Maury Regional Medical Center is making vein visualization part of their standard of care. ... more importantly, helps our staff members locate a vein that will provide good access ...
(Date:8/16/2017)... ... August 16, 2017 , ... With a new PD diagnosis every ... cure. , The grants are awarded through a competitive application process and reviewed ... array of backgrounds and expertise in all areas relevant to PD research. The ...
(Date:8/16/2017)... Sacramento, CA (PRWEB) , ... August 16, 2017 ... ... ($10.99, paperback, 9781498499613; $5.99, eBook, 9781498499620    ) shares that during the time of a ... as reminding Strawn of God's love, and all the many ways God shows ...
Breaking Medicine News(10 mins):