News & Media

    Charleston Laboratories, Inc. Investigational New Drug CL-108 “Safe to Proceed Testing in Man.”

    Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today that the U.S. Food and Drug Administration has reviewed Charleston Labs’ IND Application and granted permission to initiate the first clinical study.

    “We are very pleased that the Agency has been able to review our Application within 30 days, “ Mr. John Ameling, Vice President, Regulatory Affairs, Charleston Laboratories, said, “and that they have indicated we are “safe to proceed in testing CL-108 in man.”

    The protocol for the first study, a pharmacokinetic study designed to demonstrate the immediate- release characteristics of CL-108 compared to standard drugs, has been approved by an independent institutional review board and is set to begin in January 2009.

    All clinical studies for Charleston Laboratories are being overseen by SRC, Inc., a contract research organization based in Jupiter, Florida that is renowned for its clinical trials on patients’ symptoms (such as nausea and vomiting) and its record of drug approvals by regulatory authorities in the U.S. and worldwide.