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A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

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Trial Profile

A Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor Fluctuations

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2024

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At a glance

  • Drugs Levodopa/carbidopa (Primary) ; Levodopa/carbidopa
  • Indications Parkinson's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms RISE-PD
  • Sponsors Amneal Pharmaceuticals; IMPAX Laboratories

    • Most Recent Events

    • 08 Feb 2024 According to an Amneal Pharmaceuticals media release, company has provided a Complete Response resubmission to the U.S. Food and Drug Administration (FDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules for the treatment of Parkinsons disease.
    • 25 Jan 2024 Results presented in a Knight Therapeutics Media Release.
    • 25 Jan 2024 According to a Knight Therapeutics media release, company announced that it has entered into an exclusive license agreement with Amneal Pharmaceuticals, Inc., granting Knight the exclusive rights to seek regulatory approval and commercialize IPX203 in Canada and Latin America.
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