A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

Completed
Phase of Trial: Phase III

Latest Information Update: 29 May 2018

At a glance

  • Drugs Levodopa (Primary)
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms OFF Phenomena; SPAN-PD
  • Sponsors Acorda Therapeutics
  • Most Recent Events

    • 29 May 2018 According to an Acorda Therapeutics media release, based on the data from this trial, European Medicines Agency has completed formal validation of Marketing Authorization Application for INBRIJA.
    • 26 Mar 2018 According to an Acorda Therapeutics media release, based on the data from this trial, company has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for INBRIJA.
    • 20 Feb 2018 According to an Acorda Therapeutics media release, based on the data from SPAN-PD trial and two long-term safety studies , the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018.
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