PHOENIXVILLE, PA — PleoPharma, Inc. has announced promising results from a Phase 2b study evaluating its leading drug candidate, PP-01, intended for mitigating Cannabis Withdrawal Syndrome. Conducted across 22 US addiction centers, the randomized, double-blind, placebo-controlled trial involved 234 participants aged 18-55 seeking to discontinue cannabis use. The study revealed statistically significant reductions in withdrawal symptoms in those treated with PP-01 compared to placebo, with the highest dosage showing particularly impactful results (primary endpoint p=0.02). Importantly, PP-01 was well tolerated, exhibiting no safety concerns.
As the first potential treatment for this condition, PP-01 fills a critical gap in addressing the growing prevalence of Cannabis Use Disorder, reported to affect approximately 19.2 million Americans in 2023. Despite the increasing number seeking treatment, no FDA-approved medications currently exist for this syndrome.
Ginger Constantine, MD, CEO of PleoPharma, emphasized the drug’s potential: “The completed Phase 1 and Phase 2 studies demonstrate that PP-01 has the potential to help those who suffer from cannabis withdrawal when attempting to discontinue cannabis.” She acknowledged the responsible use of cannabis by many but highlighted the need for treatment options for those developing dependence.
PP-01’s dual mechanism targets suppressed CB1 receptors and neurotransmitter dysregulation in the brain’s reward pathways. Designed as a once-daily oral medication administered before bedtime, it promises rapid and sustained efficacy with excellent safety and tolerability.
With Phase 3 planning underway, guided by ongoing discussions with the FDA, PleoPharma aims to advance PP-01’s development, potentially offering health professionals a new tool to aid patients struggling with cannabis dependence.
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