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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

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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: 07 Feb 2025

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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

Most Recent Events

  • 04 Feb 2025 According to a Supernus Pharmaceuticals media release, the company announced that the U.S. Food and Drug Administration (FDA) approved ONAPGO (apomorphine hydrochloride) injection, formerly known as SPN-830, as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinsons disease (PD).
  • 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.

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