Charleston Life Sciences

Charleston Laboratories Inc. has finished preparation for the first round of Phase III clinical trials of CL-108, an opioid painkiller with less of the usual associated side effects of nausea and vomiting.

The specialty pharmaceutical company announced Monday that it has completed its testing of a Nausea-Prone Questionnaire for use in Phase III trials.

“All 65 patients were able to understand and use the NPQ easily, providing information predictive of nausea or vomiting,” said Dr. Bernard Schachtel, chief medical officer for Charleston Laboratories. “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.”

The Phase III study will be a double-blind, randomized, placebo-controlled, multiple-dose trial on more than 1,000 patients with post-operative pain. It is set to take place in universities and research centers across the U.S. and will be aided by the questionnaire.

“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,” CEO Paul Bosse said.