PHOENIXVILLE, PA – PleoPharma, Inc. recently presented new data from its Phase 1b study on Cannabis Withdrawal Syndrome (CWS) at the American Academy of Addiction Psychiatry’s annual meeting in Naples, FL. The study focused on the investigational drug PP-01 and its potential to address cannabis withdrawal symptoms in individuals with moderate to severe Cannabis Use Disorder (CUD).
The CAN-001 study evaluated the effects of PP-01, a dual-mechanism agent combining nabilone and gabapentin in tapered doses. Results demonstrated that PP-01 significantly reduced withdrawal symptoms compared to a placebo, with improvements apparent as early as four hours after the first dose. The benefits, including fewer cravings, better sleep, and reduced discomfort from withdrawal symptoms, were sustained through the five-day study period.
“We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01,” said Dr. Shelli Graham, Senior Vice-President of Medical/Clinical Research at PleoPharma. “We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3.”
Study participants, who reported an average cannabis use of 3.5 grams per day with a mean age of first use at 14, demonstrated overall positive outcomes when treated with PP-01. Adverse events were mild, with no serious incidents reported in the PP-01 group, highlighting both the safety and tolerability of the treatment.
Cannabis Withdrawal Syndrome remains a significant challenge for those attempting to reduce or quit their use of cannabis, as symptoms can undermine efforts to seek help or maintain abstinence. According to federal data, approximately 19.2 million Americans had CUD in 2023, with 1.64 million individuals receiving treatment for cannabis-related issues. Among these, withdrawal symptoms serve as a major barrier to recovery.
With no FDA-approved treatments currently available for CWS or CUD, PP-01 could address a critical gap in care. The number of individuals seeking treatment for cannabis-related health issues has risen by an average of 28% annually since 2018, underscoring the growing demand for effective solutions.
PleoPharma’s findings contribute to the growing field of research aimed at supporting individuals with cannabis dependence. As the company prepares PP-01 to advance into Phase 3 trials, this drug could represent a step forward in meeting the needs of a substantial and underserved population.
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