Baclofen/naltrexone/sorbitol - Pharnext

Drug Profile

Baclofen/naltrexone/sorbitol - Pharnext

Alternative Names: (RS)-baclofen/D-sorbitol/naltrexone; (RS)-baclofen/naltrexone/D-sorbitol; Baclofen/sorbitol/naltrexone; Naltrexone/baclofen/sorbitol; Naltrexone/sorbitol/baclofen; PXT 3003; PXT-03003; Sorbitol/baclofen/naltrexone; Sorbitol/naltrexone/baclofen

Latest Information Update: 25 Oct 2018

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At a glance

  • Originator Pharnext
  • Class Aminobutyric acids; Analgesics; Antispastics; Cyclopropanes; Morphinans; Muscle relaxants; Small molecules; Sugar alcohols
  • Mechanism of Action GABA B receptor agonists; Opioid receptor antagonists; PMP22 protein inhibitors
  • Orphan Drug Status

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

    Yes - Charcot-Marie-Tooth disease
  • New Molecular Entity No

Highest Development Phases

  • Phase III Charcot-Marie-Tooth disease

Most Recent Events

  • 01 Sep 2018 Pharnext SA completes the phase III PLEO-CMT trial in Charcot-Marie-Tooth disease (In adolescents, In adults) in Belgium, Canada, France, Germany, Netherlands, Spain, United Kingdom and USA (NCT02579759)
  • 10 Jul 2018 The European Medicines Agency approves Paediatric Investigation Plan for baclofen/naltrexone/sorbitol in Charcot-Marie-Tooth disease type 1A
  • 14 Jun 2018 The China Food and Drug Administration grants a priority review to baclofen/naltrexone/sorbitol for Charcot-Marie-Tooth Type 1A disease
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