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A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain After Abdominoplasty

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs PF 614 (Primary) ; Oxycodone
  • Indications Postoperative pain
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Ensysce Biosciences

Most Recent Events

  • 10 Mar 2025 According to an Ensysce Biosciences media release, company is finalizing the selection of clinical sites and an experienced team to execute PF614 phase 3 trial to remain on track to submit PF614 New Drug Application in 2026.
  • 10 Mar 2025 According to an Ensysce Biosciences media release, the company announced that they have received feedback from the FDA on PF614 phase 3 study design and company is now and are now taking steps to prepare for the expected start of enrollment of this clinical study in the second quarter of 2025.
  • 24 Sep 2024 Status changed to not yet recruiting.

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