Methylphenidate sustained release - DURECT

Drug Profile

Methylphenidate sustained release - DURECT

Alternative Names: ORADUR-ADHD; ORADUR-Methylphenidate

Latest Information Update: 09 Oct 2015

Price : $50

At a glance

  • Originator DURECT Corporation
  • Developer DURECT Corporation; Orient Pharma
  • Class Phenylacetates; Piperidines; Sleep disorder therapies; Small molecules
  • Mechanism of Action Adrenergic receptor modulators; Central nervous system stimulants; Dopamine release stimulants
  • 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 No
  • Available For Licensing Yes - Attention-deficit hyperactivity disorder

Highest Development Phases

  • Phase III Attention-deficit hyperactivity disorder

Most Recent Events

  • 01 Jun 2015 Phase-III clinical trials in Attention-deficit hyperactivity disorder (In children, In adolescents) in Taiwan (PO)
  • 07 Aug 2013 Methylphenidate sustained release - DURECT is available for licensing in USA, Europe, Japan (excluding Asia, Pacific Rim countries) (http://www.durect.com)
  • 01 Aug 2013 DURECT Corporation and Orient Pharma select the lead formulation for Methylphenidate sustained release for Attention-deficit hyperactivity disorder
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