PleoPharma Secures $6.5 Million Grant to Advance Treatment for Cannabis Withdrawal Syndrome
PleoPharma, a biotech company focused on cannabis-related health issues, has been awarded a $6.5 million grant from the National Institute on Drug Abuse (NIDA) to support a Phase 3 clinical trial of its investigational treatment, PP-01, for cannabis withdrawal symptoms in adults with cannabis use disorder.
The grant will fund the company’s CAN-004 trial, which aims to evaluate the safety and efficacy of PP-01 in adults with moderate to severe cannabis use disorder. The treatment is designed to alleviate withdrawal symptoms, such as sleep problems, anxiety, irritability, and physical symptoms, which can complicate efforts to quit and lead to relapse.
Cannabis use disorder affects over 19 million people in the United States, according to the Substance Abuse and Mental Health Services Administration (SAMHSA). Despite its prevalence, there are currently no FDA-approved pharmacological treatments for cannabis withdrawal syndrome or cannabis use disorder.
The grant is a significant milestone for PleoPharma, which has previously completed Phase 1 and Phase 2b studies of PP-01. The Phase 2b trial demonstrated a dose response and no serious adverse events, and the treatment received Fast Track designation from the FDA.
“We are thrilled to receive this grant, which recognizes the significant unmet need for a treatment for cannabis use disorder,” said Shelli Grahm, senior vice president of medical and clinical research at PleoPharma. “This funding will enable us to advance our Phase 3 program and build the clinical evidence needed to bring a much-needed treatment option to adults living with cannabis use disorder.”
The company’s CEO, Ginger Constantine, emphasized the importance of addressing cannabis use disorder with the same scientific rigor and medical attention as other substance use disorders. “We are grateful for NIDA’s support as we work to advance a potential medication-assisted treatment option that can help patients with cannabis dependence remain engaged in treatment and achieve recovery,” she said.
The CAN-004 trial is currently underway, with the first patient dosed in June 2026. The results of the trial are expected to provide crucial insights into the safety and efficacy of PP-01 as a treatment for cannabis withdrawal syndrome.
