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™)
Phase of Trial: Phase III
Latest Information Update: 29 Aug 2017
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms OFF Phenomena; SPAN-PD
- Sponsors Acorda Therapeutics
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History