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Phentermine/topiramate - VIVUS

Drug Profile

Phentermine/topiramate - VIVUS

Alternative Names: Phentermine and topiramate extended-release capsules - VIVUS; Phentermine/CR topiramate - VIVUS; Qnexa; Qsiva; Qsymia; Topiramate/phentermine; VI-0521

Latest Information Update: 14 Oct 2019

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At a glance

  • Originator VIVUS
  • Developer Alvogen; VIVUS
  • Class Amphetamines; Anorectics; Hexoses; Ketoses; Small molecules; Sulfonic acids
  • Mechanism of Action Adrenergic receptor agonists; AMPA receptor antagonists; Carbonic anhydrase inhibitors; Central nervous system stimulants; GABA A receptor agonists; Glutamate agonists; Kainic acid receptor antagonists; Neurotransmitter stimulants; Sodium channel antagonists
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Marketed Obesity
  • Phase II Sleep apnoea syndrome; Type 2 diabetes mellitus

Most Recent Events

  • 07 Oct 2019 European regulatory agencies in Sweden, Denmark, Finland, Iceland, Norway, and Poland accept MAA on a decentralised basis for phentermine/topiramate for Obesity
  • 07 Oct 2019 VIVUS anticipates the completion of the MAA assessment and Marketing Authorizations to begin in the second half of 2020
  • 20 Aug 2019 Efficacy and safety data from a phase II trial in Obesity released by VIVUS
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