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: 26 Mar 2018
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms OFF Phenomena; SPAN-PD
- Sponsors Acorda Therapeutics
- 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.
- 15 Feb 2018 According to an Acorda Therapeutics media release, the FDA is expected to inform the Company if the submission filed in Dec 2017 has been deemed complete and permits a full review, in Feb 2018. The Company expects to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in Q1 2018.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History