Navigation Links
Strong Efficacy Data Prompt Charleston Laboratories to Halt Phase 3 Study of CL-108 in Patients with Moderate to Severe Acute Pain
Date:10/29/2013

JUPITER, Fla., Oct. 29, 2013 /PRNewswire/ -- Charleston Laboratories, Inc, an emerging specialty pharmaceutical company focused on the research and development of novel pain products, announced today that it has completed its Phase 3 clinical trial of CL-108 at the midway point.  (CL-108 is a strong pain-reliever designed to also prevent nausea and vomiting.)  An independent Data Monitoring Committee reviewed the safety and efficacy results in an interim analysis and notified Charleston Labs that the study should be stopped because both efficacy endpoints of the study have been met.  The recommendation was based on the demonstration of the safety of CL-108, the significant (P<.01) effect on opioid-induced nausea and vomiting (OINV) compared to a commercial product, and the significant (P<.01) relief of moderate to severe pain.  The Company anticipates filing a new drug application with the FDA upon finalization of clinical studies in the coming year.

"This recommendation by the Data Monitoring Committee is a welcome outcome for Charleston Labs and for patients with acute moderate to severe pain," said Dr. Bernard Schachtel, Chief Scientific Officer of Charleston Labs.  "The early completion of this Phase 3 trial allows us to advance the development of CL-108, which combines an anti-emetic medication with an opioid analgesic for improved treatment of patients with acute moderate to severe pain.  The study results also represent confirmation of our pipeline and our research objective, to investigate and develop safe, effective analgesic medications without the side effects of nausea and vomiting." 

"Nausea and vomiting are the most common and untoward side effects of opioid medications and have a significant impact on patients' lives and the phys
'/>"/>

SOURCE Charleston Laboratories, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Frost & Sullivan Recognizes the Strong Adaptability of ActiveHealths CareEngine Solution
2. New Poll Finds Strong Support For Effective FDA Regulation of Compounding Pharmacies
3. The Strongly Growing Chinese Heart Valve Market Has A Number Of Distinct Features That Will Challenge Competitors
4. Chinas Strong Economic Growth and Healthcare Investments Generate Success for CPhI
5. Building Stronger Relationships with Key Opinion Leaders Ignites Need for Medical Science Liaisons
6. STAAR Surgical Reports Strong Second Quarter Financial Results
7. Strong Sales and Healthcare Reforms Benefit Earnings - Research Report on Gilead, Pfizer, Merck, AbbVie, and LifePoint
8. Pain Management Therapeutics Market to 2019 - Impact of Patent Expiries Offset by Demand for Neuropathic and Rheumatoid Pain Medications and Strong Pipeline
9. ASCO Impact Report from Encuity Research Indicates Strong Interest in New Treatments for Melanoma and Cervical Cancer
10. Parametrics Medical, LLC Announces the Release of Their Coll-e-Strong Line of Soft Tissue Allografts
11. Economic Growth In Latin America Fueling Strong Revenue Growth For Interventional Cardiology Devices
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/18/2014)... 2014  In a policy paper ... nation,s largest lesbian, gay, bisexual and transgender (LGBT) ... Truvada for Pre-Exposure Prophylaxis (PrEP). PrEP is any ... the spread of a disease or infection prior ... anti-HIV drug combination currently approved for PrEP, which ...
(Date:10/17/2014)... CHAPEL HILL, N.C. , Oct. 17, 2014 ... key insights is a critical success factor in ... companies must develop market research organizations that effectively ... their location, specialty or service area. ... groups create value and earn recognition from internal ...
(Date:10/17/2014)... THOUSAND OAKS, Calif. , Oct. 17, 2014 /PRNewswire/ ... appointment of R. Sanders Williams , M.D., president ... L. Mahley Distinguished Professor.  "We are ... the Amgen Board," said Robert A. Bradway , ... deep and distinguished experience in academic medicine and his ...
Breaking Medicine Technology:HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 2HRC Endorses PrEP, Calls for Bold Action to Expand Access to Anti-HIV Drug 3Effective Training Programs for Market Research Groups can Boost Overall Organizational Success 2Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 2Amgen Announces Appointment Of R. Sanders Williams To Board Of Directors 3
... announced today it has received two Class III Medical ... ASSURE Hernia Repair Meshes. REVIVE and ASSURE ... synthetic tissue scaffold. The Biomerix Biomaterial is ... extracellular matrix, a biological structure that supports tissue repair ...
... PHILADELPHIA, April 19, 2011 Premier Research Group Limited ... to D-TARGET, a Premier Research Company. With the continued ... and commercial demands in the medical device industry, Premier ...       D-TARGET was founded ...
Cached Medicine Technology:Biomerix Awarded Two Device Licenses by Health Canada 2Premier Research Re-brands its Medical Device Business Unit to D-TARGET 2
(Date:10/20/2014)... Unveiled at the Sept. 18 board meeting, The Center for ... ROI on membership dues at 12.5. In other words, for ... value to member hospitals. The calculation used to determine member ... , “This is the first time we’ve actually been able ... is really sound,” said Bill Ryan , president and ...
(Date:10/19/2014)... Hastings and Hastings, a Phoenix personal ... throughout the greater Phoenix area and across Arizona reports ... to catastrophic automobile accidents. Statistics have indicated a steady ... Arizona. As such, Hastings and Hastings has seen a ... those who have been injured through no fault of ...
(Date:10/19/2014)... Having been working in the garment industry for ... needs. According to James, one of the company’s top designers, ... with high-low skirts that add beauty to them. Chiffon floor ... has unveiled its new selection of 2014 long prom dresses. ... new items are available in over 20 popular designs. The ...
(Date:10/19/2014)... October 20, 2014 Stephen T. Greenberg, M.D., ... nominated for the 10th consecutive year as one of Long ... Greenberg was also been nominated as the best provider for ... nominated as best Day Spa and best Laser Treatment center ... 14th and readers can vote for the contest once per ...
(Date:10/19/2014)... 2014 Nearly 9,000 transvaginal mesh lawsuits ... & Johnson’s Ethicon unit have now been centralized in ... proceedings are continuing to move forward, Bernstein Liebhard LLP ... filed over products part of Ethicon Inc.’s line of ... October 11th, 2014, which showed an additional 1,600 claims ...
Breaking Medicine News(10 mins):Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 3Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 4Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 2Health News:Hastings And Hastings Reports Record Demand In 2014 For Legal Representation With Regard To Catastrophic Automobile Accidents 3Health News:2014 Long Prom Dresses From LunaDress Now Available In Over 20 Popular Designs 2Health News:Dr. Stephen T. Greenberg – Nominated for the 10th Consecutive Year for One of Long Island’s Best Cosmetic Surgeons for 2015 by the Long Island Press 2Health News:Transvaginal Mesh Litigations in New Jersey Tally More than 8,700 Lawsuits against C.R. Bard and Ethicon, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Litigations in New Jersey Tally More than 8,700 Lawsuits against C.R. Bard and Ethicon, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Litigations in New Jersey Tally More than 8,700 Lawsuits against C.R. Bard and Ethicon, Bernstein Liebhard LLP Reports 4
... that those who indulged in six or more cups of ... in risk of type 2 diabetes, vis a vis those ... able to place their finger on the key factor in ... that the presence of antioxidants and minerals in coffee contributes ...
... Auditor General criticized the medical system in the Indian ... out medical relief //services in the event of any ... after auditing important installations of the railways associated with ... Services in Railways", the report said that most railways ...
... The American Heart Association (AHA) laid a new set ... were offered by various organizations //such as U.S. Dietary ... from the National Academy of Sciences. ,All ... similar rules laid down. The familiar rules mentioned by ...
... activity with tremendous health and psychological benefits but if one ... ,The common perception is that sand, which is soft ... on the joints. But physicians warn that just the opposite ... you run on irregular, inconsistent surface like sand, the forces ...
... symptoms of Alzheimer’s disease and Dementia could be reversed ... patient improves by diagnosing the underlying causes and initiating ... ,What you don’t know about Alzheimer’s disease could hurt ... Women’s HealthSource. That’s why it’s important to seek medical ...
... the investigators at John Hopkins Children’s Center//, patient’s safety system ... medication errors into a computer database. ,Hopkins ... and reporting on the errors voluntarily plus steps taken to ... are not new, but few studies have looked at the ...
Cached Medicine News:Health News:Voluntary Error-Reporting System Ensures Patient Safety 2Health News:Voluntary Error-Reporting System Ensures Patient Safety 3Health News:Voluntary Error-Reporting System Ensures Patient Safety 4
OptiTape - Optically Clear sealing tape for OmniUltra PCR plates plus universal dispenser. 250 sheets....
Inquire...
The MicroAmp Centrifuge Adapter accomodates a single MicroAmp Reaction Tube with Cap and fits a standard microcentrifuge rotor. The adapter can be used up to 15,000 x g and should be used in pairs to...
... steel with stove enamel coated (RAL 7035 grey) ... Front, back and side windows 6 ... Internal adjustable tempered glass shelf ... Lighting 600 lux AC ...
Medicine Products: