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A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

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Trial Profile

A Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy Arbaclofen ER Tablets to Placebo and Baclofen Tablets, USP for the Treatment of Spasticity in Patients With Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2022

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At a glance

  • Drugs Arbaclofen (Primary) ; Baclofen
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors Osmotica Pharmaceutical; RVL Pharmaceuticals

    • Most Recent Events

    • 18 Mar 2020 According to Osmotica Pharmaceutical media release, during the second quarter of 2020, the company intends to file an amended NDA for arbaclofen ER, a potential treatment for spasticity in patients with Multiple Sclerosis.
    • 21 Apr 2016 Results (n=354) presented at the 68th Annual Meeting of the American Academy of Neurology.
    • 28 Sep 2015 According to Osmotica Pharmaceutical media release, the US FDA has accepted for filing a New Drug Application (NDA) for arbaclofen extended release tablet formulation (Ontinua) for alleviation of spasticity associated with multiple sclerosis.
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