FDA GRANTS FAST TRACK DESIGNATION TO PLEOPHARMA, INC's INVESTIGATIONAL NEW DRUG, PP-01, FOR THE MITIGATION OF CANNABIS WITHDRAWAL SYMPTOMS IN PATIENTS WITH CANNABIS USE DISORDER: A POTENTIAL FIRST IN CLASS TREATMENT

Fast Track Designation highlights the potential of PP-01 to address a serious and unmet need for patients with Cannabis Use Disorder

Phase 3 Preparations Underway

PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder.   

"We are pleased that PP-01 has been granted Fast Track designation and are grateful to the FDA for recognizing the significance of cannabis withdrawal for the growing population with cannabis use disorder," said Ginger Constantine MD, CEO of PleoPharma.

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier (FDA.gov).  In addition, a drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate's development plan as well as possible eligibility for rolling and priority reviews.

About cannabis withdrawal/cannabis use disorder
The US Government (SAMHSA) reported that in 2023, ~19.2 million Americans had cannabis use disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The reported number of individuals who received treatment for cannabis related health problems has grown by an average of 27% annually from 2018 to 2023 (samhsa.gov). People with cannabis use disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of either cannabis withdrawal syndrome or cannabis use disorder.

"We recognize that many people do use cannabis without becoming dependent", said Ginger Constantine, "but as with alcohol, some may develop a dependence (use disorder) that may be sustained and worsened by withdrawal symptoms. Our mission is to provide a treatment option for those who want help discontinuing cannabis."

About PP-01
PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering a Phase 3 clinical trial and has the potential to be the first-in-class treatment to mitigate the withdrawal syndrome experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended to be a once daily oral product with a rapid onset of action and an excellent safety and tolerability profile.

About PleoPharma, Inc.
PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis related health problems.

The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs.

For more information on PleoPharma Inc., please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at [email protected].

This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

SOURCE PleoPharma, Inc