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Related Experiment Videos

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

Lynn R Webster1

  • 1Lifetree Clinical Research and Pain Clinic, Salt Lake City, Utah, USA. lynnw@lifetreepain.com

Expert Opinion on Investigational Drugs
|February 17, 2007
PubMed
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PTI-821, a novel long-acting oxycodone formulation, shows promise for effective pain relief with abuse-deterrent technology. Preliminary data indicate significant pain reduction compared to placebo, suggesting improved safety for chronic pain management.

Area of Science:

  • Pharmacology
  • Pain Management
  • Drug Delivery Systems

Background:

  • Conventional controlled-release oxycodone products present safety concerns and abuse potential.
  • There is a need for effective long-acting opioid formulations with reduced abuse liability.
  • Pain Therapeutics developed PTI-821, a long-acting oxycodone formulation with abuse-deterrent gel-cap technology.

Purpose of the Study:

  • To present preliminary data on PTI-821, a novel abuse-deterrent oxycodone formulation.
  • To discuss the potential clinical applications of PTI-821 in pain management.
  • To evaluate the safety and efficacy of PTI-821 compared to placebo.

Main Methods:

  • Review of preliminary pharmacokinetic data from three studies.
  • Analysis of results from a Phase III, randomized, double-blind, placebo-controlled clinical efficacy trial.

Related Experiment Videos

  • Assessment of abuse-deterrent properties via gel-cap technology.

    • Main Results:

    • PTI-821 demonstrated statistically significant pain reduction compared to placebo (p < 0.05) in the primary efficacy endpoint.
    • Preliminary pharmacokinetic data support the long-acting profile of PTI-821.
    • The gel-cap technology is designed to deter abuse of the oxycodone formulation.

    Conclusions:

    • PTI-821 shows potential as a safer alternative to conventional controlled-release oxycodone for managing pain.
    • The abuse-deterrent formulation may reduce the risk of misuse and diversion.
    • Further large-scale clinical studies are ongoing to confirm efficacy and safety.