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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-03003; PXT-3003; Sorbitol/baclofen/naltrexone; Sorbitol/naltrexone/baclofen; SYNGILITY

Latest Information Update: 09 Jan 2020

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At a glance

  • Originator Pharnext
  • Developer GeneNet; 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

  • 08 Jan 2020 Interim efficacy data from a phase III trial in Charcot-Marie Tooth disease released by Pharnext
  • 30 Aug 2019 Pharnext plans to file an NDA in Charcot-Marie-Tooth disease (In adolescents, In adults)
  • 30 Aug 2019 The US FDA recommends conduction of an additional phase III trial in Charcot-Marie-Tooth disease, in support of a prospective NDA application in the indication
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