PTI-821: sustained-release oxycodone using gel-cap technology.

PTI-821 is a long-acting formulation of oxycodone that is intended to deter abuse through its gel-cap technology. Produced by Pain Therapeutics in alliance with King Pharmaceuticals, PTI-821 is designed to provide strong pain relief with the intent of offering greater safety than is presently available from conventional controlled-release oxycodone products. This paper presents the available preliminary data on PTI-821 and discusses their potential clinical applications. The results of three pharmacokinetics studies and one Phase III, randomized, double-blind, clinical efficacy trial have been published in abstract form. PTI-821 has demonstrated a statistically significant difference from placebo (p < 0.05) in the efficacy study's primary end point: percentage decrease in pain scores. A further large, clinical study is in progress.

RCT Entities:   Population Interventions Outcomes