The Fast Track Designation underscores PP-01’s potential to address a critical unmet need for individuals with Cannabis Use Disorder.
Phase 3 trials are underway.
PHOENIXVILLE, Pa., Feb. 13, 2025 — PleoPharma, Inc., a private company focused on developing cannabis-related health treatments, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead product, for mitigating Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder.
“We are pleased that PP-01 received Fast Track designation and thank the FDA for acknowledging the significance of cannabis withdrawal in the growing population with cannabis use disorder,” stated Ginger Constantine MD, CEO of PleoPharma.
Fast Track is a process designed to accelerate the development and review of drugs for serious conditions and unmet medical needs. Its goal is to get essential new drugs to patients sooner (FDA.gov). Additionally, a drug receiving Fast Track designation is eligible for increased FDA meetings and written communication to discuss development plans and potential rolling and priority reviews.
About cannabis withdrawal/cannabis use disorder
The US Government (SAMHSA) reported that in 2023, approximately 19.2 million Americans had cannabis use disorder, with 1.64 million receiving treatment (around 500,000 inpatient, approximately 1.1 million outpatient). The number of individuals receiving treatment for cannabis-related health issues grew by an average of 27% annually from 2018 to 2023. People with cannabis use disorder often experience significant withdrawal symptoms. Currently, there are no FDA-approved medications for cannabis withdrawal syndrome or cannabis use disorder.
“We understand that many cannabis users do not become dependent,” said Ginger Constantine, “but, like alcohol, some develop dependence (use disorder) that can be sustained and worsened by withdrawal symptoms. Our aim is to provide treatment for those seeking help to discontinue cannabis.”
About PP-01
PP-01 is an investigational dual-mechanism product targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering Phase 3 clinical trials and has the potential to be the first-in-class treatment to mitigate withdrawal syndrome in patients with cannabis use disorder (dependence/addiction). PP-01 is designed as a once-daily oral medication with rapid onset and a favorable safety and tolerability profile.
About PleoPharma, Inc.
PleoPharma, Inc. is a clinical-stage development company in the neuropsych and addiction sector, focusing on solutions for individuals with cannabis addiction and other cannabis-related health issues.
The PleoPharma team includes a world-class management team and board of directors with a history of multiple high-value exits, over 50 worldwide product approvals, and over 100 INDs.
For more information on PleoPharma Inc., please visit or email Dawn Halkuff, head of Investor Relations at .
This release contains ‘forward-looking statements’ regarding PleoPharma, Inc.’s operations; actual results may differ from its expectations, estimates, and projections. Therefore, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts are forward-looking statements reflecting the current beliefs and expectations of PleoPharma’s management. These forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially. PleoPharma does not undertake any obligation to update or revise any forward-looking statements to reflect changes in expectations or events, conditions, or circumstances.
SOURCE PleoPharma, Inc
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