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A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain

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Trial Profile

A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2021

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At a glance

  • Drugs Oxycodegol (Primary)
  • Indications Back pain; Pain
  • Focus Adverse reactions; Registrational
  • Acronyms SUMMIT-LTS
  • Sponsors Nektar Therapeutics

    • Most Recent Events

    • 14 Jan 2020 According to a Nektar Therapeutics media release, the company issues a statement following a meeting with the Food and Drug Administration's Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee to discuss the New Drug Application for oxycodegol, where the Committees did not recommend approval of oxycodegol. Based on this, the Company has decided to withdraw the NDA for oxycodegol and to make no further investment into the program.
    • 20 May 2019 Status changed from active, no longer recruiting to completed.
    • 30 Jul 2018 According to a Nektar Therapeutics media release, the U.S. FDA has filed and accepted for review of the companys NDA for NKTR-181 for the treatment of chronic low back pain in adult patients new to opioid therapy. The NDA is expected to be assigned a PDUFA (Prescription Drug User Fee Act) target action date of 28 May 2019 by the FDA.

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