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
Latest Information Update: 19 Feb 2025
At a glance
- Drugs Gabapentin/nabilone PleoPharma (Primary) ; Gabapentin; Nabilone
- Indications Substance-related disorders
- Focus Therapeutic Use
- Sponsors PleoPharma
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.