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.
Webster
Lynn R
LR
Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.com
D000701:Analgesics, Opioid / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D002214:Capsules; D003692:Delayed-Action Preparations; D005782:Gels; D006801:Humans; D009294:Narcotics / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D009293:Opioid-Related Disorders / Q000517:prevention & control; D010098:Oxycodone / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D010146:Pain / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic
D000701:Analgesics, Opioid; D002214:Capsules; D003692:Delayed-Action Preparations; D005782:Gels; D009294:Narcotics; D010098:Oxycodone