Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Charleston Ends Painkiller Trial Midway | Contract Pharma

What are you searching for?

Sign in

Charleston Ends Painkiller Trial Midway

IDMC recommends closure after positive efficacy results

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Charleston Laboratories has ended its Phase III trial of CL-108 at the midway point. 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. CL-108 is a strong pain reliever designed to also prevent nausea and vomiting.

The recommendation was based on the demonstration of the safety of CL-108, the significant effect on opioid-induced nausea and vomiting (OINV) compared to a commercial product, and the significant relief of moderate to severe pain. Charleston anticipates filing an NDA with the FDA upon finalization of clinical studies in the coming year.

CL-108 is a novel analgesic, combining 12.5 mg of immediate-release promethazine with 7.5 mg of hydrocodone and 325 mg of acetaminophen. It is indicated for patients who suffer from moderate to severe acute pain, such as post-operative pain, while significantly reducing or eliminating OINV.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics