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A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain

Trial Profile

A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jul 2018

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At a glance

  • Drugs Oxycodegol (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Acronyms SUMMIT-07
  • Sponsors Nektar Therapeutics
  • Most Recent Events

    • 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.
    • 14 Jun 2018 According to a Nektar Therapeutics media release, data from this study were presented at the 80th Annual Scientific Meeting of the College on Problems of Drug Dependence (CPDD).
    • 31 May 2018 According to a Nektar Therapeutics media release, the company has submitted a NDA to the US FDA for NKTR-181, a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy, based on the data of: Efficacy study (243040); a long-term 52-week safety study (254129); pharmacokinetic/pharmacodynamic studies in over 450 subjects; and two human abuse potential studies of NKTR-181 versus an oxycodone control in recreational drug users (220652 and 282808)
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