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A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Trial Profile

A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2018

At a glance

  • Drugs DMI 9523 (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Ampio Pharmaceuticals
  • Most Recent Events

    • 07 Nov 2018 According to an Ampio media release, the company disagreed with the Office of Tissue and Advanced Therapies (OTAT) decision regarding the insufficiency of AP-003-C as a registrational trial and formally requested FDA to reconsider the decision.
    • 07 Nov 2018 According to an Ampio media release, the FDA has accepted a Type C meeting proposal from Ampio that could lead to the resolution of the dispute regarding the acceptability of AP-003-C as the 2nd of the two required Pivotal trials for the filing of a BLA and scheduled the meeting before the end of November 2018.
    • 04 Oct 2018 According to an Ampio media release, company is continuing discussions with the FDA to determine if the pivotal AP-003-C study is the final trial required to support the Ampion BLA. Should another trial be required, the Company will move quickly to meet the FDA requirements under a Special Protocol Assessment (SPA).
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