November 25, 2024 – PleoPharma has announced positive results from its proof-of-concept study of PP-01, a treatment aimed at alleviating symptoms associated with Cannabis Withdrawal Syndrome (CWS). The results, which were sustained over the five-day study period, suggest that PP-01 could be a groundbreaking solution for those struggling with cannabis dependence and withdrawal.
Study Findings: Safety and Effectiveness of PP-01
The study, which involved participants with an average cannabis consumption of 3.5 grams per day, demonstrated significant improvements in key areas such as reduced cravings, better sleep, and less discomfort from withdrawal symptoms. These effects were observed over the five-day study period, marking a promising potential for PP-01 as a treatment option.
Dr. Shelli Graham, Senior Vice-President of Medical/Clinical Research at PleoPharma, expressed enthusiasm about the results: “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.” PleoPharma is now preparing to move the drug into Phase 3 trials, signaling their commitment to addressing the growing issue of cannabis dependence.
Safety Profile: Mild Adverse Events and No Serious Incidents
The safety profile of PP-01 was favorable, with mild adverse events reported and no serious incidents in the treatment group. This highlights the drug’s tolerability and supports its potential as a safe option for individuals dealing with cannabis withdrawal.
Cannabis Withdrawal Syndrome: A Growing Challenge
Cannabis Withdrawal Syndrome is a significant obstacle for individuals attempting to reduce or quit cannabis use. Symptoms such as irritability, anxiety, and sleep disturbances often undermine efforts to seek help or maintain abstinence. According to federal data, approximately 19.2 million Americans had Cannabis Use Disorder (CUD) in 2023, with 1.64 million individuals receiving treatment. Yet, there are currently no FDA-approved treatments for CWS or CUD, creating a critical gap in care for those seeking recovery.
The demand for effective treatments is rising, with the number of individuals seeking help for cannabis-related health issues increasing by an average of 28% annually since 2018. As such, PP-01 could offer a much-needed solution for a growing population in need of support.
Looking Ahead: Phase 3 Trials and the Future of PP-01
PleoPharma’s ongoing research into cannabis dependence treatments represents a significant step forward in the field, with PP-01 poised to potentially fill a gap in the current treatment landscape. The company is now preparing to advance PP-01 into Phase 3 clinical trials, moving closer to offering a FDA-approved treatment for individuals struggling with cannabis dependence and withdrawal.
With no current FDA-approved options available for treating Cannabis Withdrawal Syndrome, PP-01’s promising results could have a major impact on the lives of millions of individuals affected by cannabis use disorder. If successful, this drug could become a critical tool in the fight against cannabis addiction.
