A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Trial Profile

A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Oct 2017

At a glance

  • Drugs Levodopa (Primary)
  • Indications Parkinson's disease
  • Focus Adverse reactions; Registrational
  • Sponsors Acorda Therapeutics; Civitas Therapeutics
  • Most Recent Events

    • 29 Aug 2017 According to an Acorda Therapeutics media release, the company is planning a Type A meeting with the FDA to respond to the issues and to seek clarification of what additional information will be required for NDA resubmission.
    • 29 Aug 2017 According to an Acorda Therapeutics media release, the company has received a Refusal to File (RTF) letter from the U.S. FDA regarding its NDA for INBRIJA. In the preliminary review, FDA determined that NDA was not sufficiently complete to permit a substantive review. Reasons for the RTF are the date when the manufacturing site would be ready for inspection and a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission.
    • 29 Jun 2017 According to an Acorda Therapeutics media release, based on the data from SPAN-PD and two long-term safety studies the company has submitted a New Drug Application (NDA) as a 505(b)(2) application to the U.S. FDA for INBRIJATM (CVT-301, levodopa inhalation powder). The Company anticipates the FDA will inform about submission and full review by the end of September 2017.
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