Arbaclofen extended release - Osmotica Pharmaceutical

Drug Profile

Arbaclofen extended release - Osmotica Pharmaceutical

Alternative Names: Arbaclofen extended release tablets (AERT) - Osmotica Pharmaceutical; Ontinua ER; OS-440

Latest Information Update: 22 Nov 2016

Price : $50

At a glance

  • Originator Osmotica Pharmaceutical
  • Class Aminobutyric acids; Gastrokinetics; Muscle relaxants; Small molecules
  • Mechanism of Action GABA B receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Muscle spasticity

Most Recent Events

  • 14 Sep 2016 Adverse events and efficacy data from a phase III trial in Muscle spasticity (in patients with multiple sclerosis) presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2016)
  • 14 Sep 2016 Adverse events and efficacy data from a phase III trial in Muscle spasticity (in patients with multiple sclerosis) presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-2016)
  • 01 Jul 2016 Osmotica Pharmaceutical initiates a phase III trial for Muscle spasticity (in patients with Multiple sclerosis) in USA (PO) (NCT02869425)
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