Trial Profile
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
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 08 Nov 2023
Price :
$35
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At a glance
- Drugs Apomorphine (Primary)
- Indications Parkinson's disease
- Focus Registrational; Therapeutic Use
- Acronyms TOLEDO
- Sponsors Britannia Pharmaceuticals; STADA Arzneimittel
- 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.
- 28 Feb 2023 According to a Supernus Pharmaceuticals media release, company will be meeting with the U.S. Food and Drug Administration (FDA) in April 2023 to discuss the Complete Response Letter received in October 2022 and will announce the timing for resubmission after discussion with the FDA.