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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
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SOURCE Charleston Laboratories, Inc.
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