US-based Charleston Laboratories and its partner, Daiichi Sankyo, have started two Phase III clinical trials of CL-108, intended to treat moderate to severe acute pain while reducing nausea and vomiting, common side effects of opioids.
Charleston’s lead product in development, CL-108 is a new, bi-layered tablet containing 7.5mg of hydrocodone and 325mg of acetaminophen with 12.5mg of immediate-release promethazine.
The first Phase III trial was a randomised, double-blind, placebo- and active-controlled study conducted in patients following bunionectomy surgery at three major research centres in the US.
The second trial is being carried out at 17 research centres across the US in patients suffering from moderate to severe acute pain due to osteoarthritis of the knee or hip.
Charleston Laboratories president and CEO Paul Bosse said: "Following the announcement of our collaboration with Daiichi Sankyo, the initiation of these two clinical trials marks a critical moment in our timeline for Charleston Laboratories.
"As a result of the planning and hard work by our chief scientific officer, Dr. Bernard Schachtel, and his dedicated research staff, Charleston is already conducting the final studies to support the NDA for CL-108, which is targeted for filing with the FDA later next year."
Results of the first Phase III trial showing the safety and efficacy of CL-108 for moderate-to-severe pain with reduction of opioid-induced nausea and vomiting were reported in April 2014.
The company said that the trial was terminated early by an external Data Safety Monitoring Board because of the significant evidence of the safety and efficacy of CL-108.
Currently, the company’s product pipeline seeks to address unmet needs in opioid-induced nausea and vomiting (OINV), postoperative nausea and vomiting (PONV), chemotherapy-induced nausea and vomiting (CINV), radiation-induced nausea and vomiting (RINV), and migraine-induced nausea and vomiting (MINV).