PHOENIXVILLE, PA — PleoPharma, Inc. shared encouraging findings from its Phase 2b clinical trial of PP-01, a novel treatment for Cannabis Withdrawal Syndrome (CWS), during the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, Louisiana. The trial evaluated the safety and effectiveness of PP-01, a dual-mechanism, once-daily oral therapy, in participants with moderate to severe Cannabis Use Disorder (CUD).
During the conference, PleoPharma presented both a poster session, “Predictors of Cannabis Abstinence in a Clinical Trial,” and an oral presentation, “PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use,” based on data from their CAN-002 study.
The randomized, double-blind trial examined the impact of titrated dosages of nabilone and gabapentin in reducing withdrawal symptoms. Findings revealed that PP-01 significantly lowered Cannabis Withdrawal Scores compared to placebo (p-value < 0.02) and showed a fivefold increase in abstinence rates two weeks post-treatment. Additionally, early reductions in withdrawal symptoms during the first week of treatment were predictive of long-term abstinence.
Trial participants reported an average baseline use of 4.6 grams of cannabis per day, with the majority classified as having severe CUD by DSM-5 criteria. PP-01 demonstrated a favorable safety profile, with common mild adverse events including headache, fatigue, somnolence, nausea, and dizziness. No serious adverse events were reported.
Commenting on the progress, Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research, stated, “We are excited to be developing PP-01, which was granted Fast Track designation by the FDA, and has the potential to be the first FDA approved product to help people suffering from CWS with CUD, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3.”
The data presentation underscores PP-01’s promise as an innovative therapy for addressing the challenges of CWS, offering hope to a patient population with limited treatment options.
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