A Pivotal, Comparative Pharmacokinetic Study Characterizing the Systemic Exposure, Pharmacokinetics, Apparent Dose, Bioequivalence, and Safety of the Investigational Lidocaine Patch (ZTlido) Against Lidoderm in Healthy Subjects

Trial Profile

A Pivotal, Comparative Pharmacokinetic Study Characterizing the Systemic Exposure, Pharmacokinetics, Apparent Dose, Bioequivalence, and Safety of the Investigational Lidocaine Patch (ZTlido) Against Lidoderm in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 12 Sep 2017

At a glance

  • Drugs Lidocaine (Primary)
  • Indications Postherpetic neuralgia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Scilex Pharmaceuticals
  • Most Recent Events

    • 12 Sep 2017 According to a Sorrento Therapeutics media release, SCILEX Pharmaceuticals Inc. a majority-owned subsidiary of Sorrento, has received from the U.S. Food and Drug Administration (FDA) acknowledgement of receipt of its recently resubmitted New Drug Application (NDA) for ZTlido(lidocaine patch 1.8%) which has been considered a complete, class 2 response to the prior action letter. The PDUFA date is set for February 28, 2018 .
    • 29 Aug 2017 According to a Sorrento Therapeutics media release, data from this trial was used to resubmit the NDA and all FDA comments related to the initial NDA submission for the lead product candidate, ZTlido (lidocaine patch 1.8%) were responded by SCILEX Pharmaceuticals Inc.(a majority-owned subsidiary of Sorrento).
    • 05 Dec 2016 According to Sorrento Therapeutics media release, the full data will be resubmitted to the U.S. Food and Drug Administration (FDA) as part of the new drug application (NDA) in mid-2017.
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