A 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Levodopa (Primary)
- Indications Parkinson's disease
- Focus Adverse reactions; Registrational
- Acronyms OFF Phenomena
- Sponsors Acorda Therapeutics; Civitas Therapeutics
- 02 Mar 2018 The trial has been completed in Spain.
- 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.