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A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain

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Trial Profile

A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Sep 2021

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At a glance

  • Drugs Oxycodone/naltrexone (Primary)
  • Indications Back pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Pfizer

    • Most Recent Events

    • 19 Aug 2016 According to a Pfizer media release, the US FDA has approved Troxyca ER (oxycodone/naltrexone) for oral use, with the abuse-deterrent properties for the management of pain.
    • 28 Apr 2015 According to a Pfizer media release, the US FDA has assigned a PDUFA action date in October 2015 for the NDA for oxycodone/naltrexone [ALO 02] for the treatment of severe pain.
    • 03 May 2014 Results presented at the 33rd Annual Scientific Meeting of the American Pain Society.

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