Charleston Laboratories, Inc, an emerging specialty pharmaceutical company dedicated to reducing opioid induced nausea and vomiting (OINV) in opioid pharmaceuticals, announced today the completion of its testing of a Nausea- Prone Questionnaire, or NPQ, to be used in its Phase III clinical trials.
“An important purpose of this randomized controlled trial was to test and prove the feasibility of the NPQ,” reported Dr. Bernard Schachtel, Chief Scientific Officer at Charleston Laboratories. “All 65 patients were able to understand and use the NPQ easily, providing information predictive of nausea or vomiting. While some minor modifications of the NPQ were learned from this research,” he said, “on the basis of this study we have reasonable confidence in this instrument to identify patients who are susceptible to opioid-induced nausea and vomiting in the upcoming safety and efficacy studies.”
To evaluate the efficacy of Charleston’s first drug (CL-108) for pain relief and the reduction or elimination of OINV, arrangements are being made with clinical investigators at major universities and research centers in the US to conduct Charleston’s first Phase III study, a multi-centered double-blind, randomized, placebo-controlled, multiple-dose trial on over 1,000 patients with post- operative pain.
“Because OINV is a prevalent patient syndrome,” Dr. Schachtel added, “Charleston is also planning larger studies of the NPQ in patients exposed to opioid analgesics.”
Ray Takigiku, PhD, Chief Operating Officer at Charleston Laboratories, noted that “this type of deliberate progression from concept to design to preliminary testing and revision marks the scientific approach which Charleston is taking under Dr. Schachtel’s direction. With expert review by our Scientific Advisory Board,” Dr. Takigiku said, “we anticipate being able to use a practical and reliable screening instrument in our Phase III trials.”
“This novel Nausea-Prone Questionnaire which Dr. Schachtel has created will be very valuable to Charleston and its partners in the development of CL-108 and future pipeline,” said Paul Bosse, Chief Executive Officer at Charleston. “In fact, the NPQ could possibly one day provide medical professionals with an everyday tool to better screen and treat patients who are prone to nausea and vomiting from opioids.”
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.