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A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of VEC-162 [tasimelteon] (20 mg/day and 50 mg/day) in the treatment of primary insomnia

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Trial Profile

A multicenter, randomized, double-blind, placebo-controlled, parallel study to investigate the efficacy and safety of VEC-162 [tasimelteon] (20 mg/day and 50 mg/day) in the treatment of primary insomnia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Feb 2024

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At a glance

  • Drugs Tasimelteon (Primary)
  • Indications Insomnia
  • Focus Registrational; Therapeutic Use
  • Sponsors Vanda Pharmaceuticals
  • Most Recent Events

    • 05 Feb 2024 According to a Rani therapeutics media release, The US FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments as part of companies supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation. The FDA has assigned PDUFA date as 4 March, 2024.
    • 03 Jul 2008 Primary endpoint met; results reported in a Vanda Pharmaceuticals media release.
    • 01 May 2008 Top-line results are expected to be reported in June 2008, according to a Vana Pharmaceuticals media release..
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