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A randomized, double-blind, placebo-controlled, six-sequence crossover study evaluating the relative oral abuse potential of NKTR-181 compared to the Schedule II opioid oxycodone in healthy non-dependent recreational drug users experienced in the oral abuse of opioids who can identify drug effects that are relevant to abuse risk assessment

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A randomized, double-blind, placebo-controlled, six-sequence crossover study evaluating the relative oral abuse potential of NKTR-181 compared to the Schedule II opioid oxycodone in healthy non-dependent recreational drug users experienced in the oral abuse of opioids who can identify drug effects that are relevant to abuse risk assessment

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 16 Jan 2020

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At a glance

  • Drugs Oxycodegol (Primary) ; Oxycodone
  • Indications Back pain; Musculoskeletal pain; Pain
  • Focus Pharmacokinetics; Registrational
  • Acronyms HAP
  • 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.
    • 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.
    • 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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