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Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

Trial Profile

Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 May 2021

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At a glance

  • Drugs Apomorphine (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TOLEDO
  • Sponsors Britannia Pharmaceuticals; STADA Arzneimittel
  • Most Recent Events

    • 05 May 2021 According to a Supernus Pharmaceuticals media release, the company has recently met with the FDA to discuss the path forward for resubmission of the SPN-830 NDA. The Company now plans to resubmit the SPN-830 NDA in the second half of 2021.
    • 24 Feb 2021 According to a Supernus Pharmaceuticals media release, the company has scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the Refusal to File (RTF) letter that is received in November 2020 regarding its NDA for SPN-830.
    • 09 Nov 2020 According to a Supernus Pharmaceuticals media release, Company plans to seek guidance from the FDA, including a Type A meeting, to discuss the contents of the RTF letter and clarify the steps required for the resubmission of the NDA for SPN-830.
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