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A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms

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Trial Profile

A Phase 2, Multicenter, Randomized, Double-Blind, Multiple-Dose, Placebo Controlled Clinical Trial of Two Doses of PP-01 for the Mitigation of Cannabis Withdrawal Symptoms

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2025

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At a glance

Most Recent Events

  • 13 Feb 2025 According to a PleoPharma, Inc. media release, the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01 for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder.
  • 19 Sep 2024 According to PLEOPHARMA, INC media release, Ginger Constantine, MD, presented data from this trial at the Life Sciences PA's Life Sciences Future Conference
  • 05 Sep 2024 According to a PleoPharma, Inc. media release, planning for phase 3 study is continue in conjunction with FDA input following a recently completed End of Phase 2 FDA meeting.

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