Multicentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical Treatment
Latest Information Update: 14 May 2024
At a glance
- Drugs Apomorphine (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms TOLEDO
- Sponsors Britannia Pharmaceuticals; STADA Arzneimittel
- 08 May 2024 According to a Supernus Pharmaceuticals media release, the U.S. FDA issued a Complete Response Letter (CRL) in response to the New Drug Application for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form. The Company will announce the timing for its resubmission after further discussion with the FDA, which is expected to take place in May 2024.
- 02 Nov 2023 According to a Supernus Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its apomorphine infusion device (SPN-830) and it is now considered filed, with a user fee goal date (PDUFA date) of April 5, 2024.
- 01 Apr 2023 According to a Supernus Pharmaceuticals media release, the company met with the U.S. Food and Drug Administration (FDA) and discussed complete response letter received in October 2022. Based on this meeting, the Company expects to resubmit the New Drug Application for SPN-830 in the fourth quarter of 2023.