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A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Investigate the Safety and Efficacy of Arbaclofen Extended-Release Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Jul 2022

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At a glance

  • Drugs Arbaclofen (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Acronyms OS440-3004
  • Sponsors RVL Pharmaceuticals

Most Recent Events

  • 30 Mar 2021 According to an Osmotica Pharmaceutical media release, the company had constructive Type A meeting with the FDA and the company is exploring a number of options define a path forward, which will most likely include another clinical trial.
  • 29 Dec 2020 According to an Osmotica Pharmaceutical media release, the company intends to review the CRL with its advisors and to request a meeting with the FDA to discuss their recommendations.
  • 29 Dec 2020 According to an Osmotica Pharmaceutical media release, the USA Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for the approval of Arbaclofen extended release tablets to treat spasticity resulting from multiple sclerosis. The CRL stated that, the company did not provide adequate justification (including in its most recent NDA amendment) for the statistical analysis of the change from baseline to Day 84 in TNmAS-MAL scores.

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