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PF 614

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Drug Profile

PF 614

Alternative Names: BIO-MD™ PF614; ER Oxycodone - Ensysce Biosciences; ER Oxycodone Bio-MD™ System; Oxycodone prodrug extended release - Ensysce Biosciences; PF614; PF614-TAAP™; PRF 06014; PRF-06104

Latest Information Update: 26 Mar 2025

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At a glance

  • Originator PharmacoFore
  • Developer Ensysce Biosciences
  • Class Alkaloids; Morphine derivatives; Opioid analgesics; Small molecules
  • Mechanism of Action Opioid mu receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Pain

Most Recent Events

  • 10 Mar 2025 Ensysce Biosciences announces intention to submit NDA to US FDA for Pain in 2026
  • 24 Nov 2024 Ensysce Biosciences initiates a phase I trial for Pain (In volunteers) in USA (PO, capsule) (NCT06500793)
  • 02 Oct 2024 Ensysce Biosciences plans a phase III trial for Postoperative pain (PO) in March 2025 (NCT06602271)

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