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Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study

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Trial Profile

Maxigesic IV Bunionectomy Study- A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group and Placebo-Controlled Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2023

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At a glance

  • Drugs Ibuprofen/paracetamol (Primary) ; Ibuprofen; Paracetamol
  • Indications Postoperative pain
  • Focus Therapeutic Use
  • Sponsors AFT Pharmaceuticals

    • Most Recent Events

    • 02 May 2023 According to a Hyloris Pharmaceuticals media release, under the terms of the development collaboration agreement between Hyloris and AFT, Hyloris is eligible to receive a share on any product-related revenues, such as license fees, royalties, milestone payments, received by AFT.
    • 02 May 2023 According to a Hyloris Pharmaceuticals media release, company today announces US Food & Drug Administration has set 17 Oct 2023 as Prescription Drug User Fee Act (PDUFA) goal date, the date by which it expects to respond to the application regarding Maxigesic IV. Also, the anticipated review period of 6 months, and a potential registration of Maxigesic IV for the US market before the end of 2023.
    • 18 Apr 2023 According to a Hyloris Pharmaceuticals media release, company announced submission of Maxigesic IV packaging data requested by the US FDA.
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