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A proof-of-concept study, single-dose, cross-over, comparative bioavailability of AQS-1303 (transdermal doxylamine/pyridoxine long-acting patch), for the treatment of nausea and vomiting of pregnancy (NVP)

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Trial Profile

A proof-of-concept study, single-dose, cross-over, comparative bioavailability of AQS-1303 (transdermal doxylamine/pyridoxine long-acting patch), for the treatment of nausea and vomiting of pregnancy (NVP)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Sep 2018

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At a glance

  • Drugs Doxylamine/pyridoxine (Primary) ; Doxylamine/pyridoxine
  • Indications Nausea and vomiting
  • Focus Adverse reactions; Pharmacokinetics; Proof of concept
  • Sponsors Aequus Pharmaceuticals

    • Most Recent Events

    • 27 Aug 2018 According to an Aequus Pharmaceuticals media release, company received positive feedback from a pre-Investigational Drug Application (pre-IND) meeting with the US Food and Drug Administration, the FDA agreed that AQS1303 is a suitable candidate for the 505(b)2 abbreviated regulatory pathway for approval in the United States.
    • 31 Jan 2018 According to an Aequus Pharmaceuticals media release, this study was completed in September 2017.
    • 07 Sep 2017 According to an Aequus Pharmaceuticals media release, the company will incorporate the results from this study into a pre-Investigational New Drug (pre-IND) submission with the US Food and Drug Administration (FDA) to define the clinical strategy for regulatory approval in the US.
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