The placebo-controlled trial will include approximately 120 patients with moderate to severe cancer-related pain. A primary composite endpoint that evaluates pain reduction with an improvement in quality of life will be used to define true responder to treatment, Vancouver-based Wex said.
The company believes that the trial has a high probability of meeting its endpoint. The last study for the drug was terminated early when it became apparent that the trial would not meet its objective when based solely on pain reduction.
However, a reanalysis showed that an endpoint that combines pain reduction with an improvement in quality of life would have produced a statistically significant and clinically meaningful result, Wex said. The company added that a primary composite endpoint is commonly used in chronic pain trial, as pain assessment is subjective.
Wex said that a successful trial, along with data from previous studies, should be enough to receive new drug submission approval from Canadian regulators.