PleoPharma, Inc. Unveils Promising Results in Cannabis Withdrawal Study at Major Conference

PleoPharma, Inc., a privately owned company concentrating on health issues related to cannabis, recently presented encouraging data from their Phase 2b clinical trial at the 2025 annual meeting of The College on Problems of Drug Dependence held in New Orleans, Louisiana. This trial focused on PP-01, an investigational product aimed at alleviating symptoms associated with Cannabis Withdrawal Syndrome (CWS) in those diagnosed with Cannabis Use Disorder (CUD).

The CAN-002 study was designed as a multicenter, randomized, double-blind, placebo-controlled trial. It involved administering varying doses of PP-01 to participants in order to evaluate its efficacy and safety in lessening cannabis withdrawal symptoms. The presentation included a poster titled "Predictors of Cannabis Abstinence in a Clinical Trial" and an oral presentation on the significant mitigation of withdrawal symptoms observed in patients following treatment with PP-01.

At the outset of the trial, adult participants reported an average cannabis consumption of 4.6 grams daily, with an average initiation age of around 16.5 years. When evaluated using DSM-5 criteria, 84% of the participants were found to have severe CUD, while the remaining 16% had moderate cases of the disorder. The results indicated that PP-01 led to a significant reduction in Cannabis Withdrawal Scores as compared to placebo, achieving a P value of less than 0.02. Furthermore, those treated with PP-01 experienced a fivefold increase in abstinence two weeks post-treatment versus those receiving a placebo. The study also indicated that improvement in withdrawal symptoms during the initial week of treatment may predict the likelihood of abstinence.

The findings revealed that PP-01 was generally well-received by participants, with side effects primarily being mild and manageable. Among the most common adverse events were headaches, sleepiness, fatigue, nausea, and dizziness, without any serious complications reported.

Dr. Shelli Graham, Senior Vice-President of Medical/Clinical Research at PleoPharma, expressed excitement over the advancements being made with PP-01, emphasizing that the product was granted Fast Track designation by the FDA and holds the promise of becoming the first FDA-approved treatment for individuals grappling with CWS related to CUD. PleoPharma is currently gearing up for Phase 3 of the clinical trial, aiming to bring a much-needed solution to a growing patient demographic.

As reported by the US Government in 2023, approximately 19.2 million Americans were identified as having CUD, with around 1.64 million seeking treatment. This indicates a noticeable annual increase of approximately 28% in cannabis-related health treatment from 2018 to 2023. A significant concern lies in the withdrawal symptoms associated with CUD, which can present significant challenges for patients attempting to reduce or cease cannabis use. At present, there are no FDA-approved medications available for addressing CWS or CUD, marking a critical gap in treatment options.

PleoPharma, Inc. stands at the forefront of clinical advancement in neuropsych and addiction treatment, with PP-01 as their leading candidate aimed at becoming the first FDA-authorized medication designated for the management of CWS in individuals diagnosed with CUD. This initiative is backed by a distinguished management team and board that have previously driven numerous high-value product approvals and supported the development of over 100 Investigational New Drug (IND) applications.

For further details on PleoPharma’s innovative work and ongoing clinical trials, visit PleoPharma’s website or reach out to Dawn Halkuff, head of Investor Relations, via email at [email protected]