PHOENIXVILLE, Pa. — The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, PleoPharma Inc.’s investigational new drug (IND) application for the mitigation of cannabis withdrawal syndrome.
“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 CEO Ginger Constantine, MD.
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, according to the FDA. 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, about 19.2 million Americans had cannabis use disorder with 1.64 million people receiving treatment (500,000 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. 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 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, more than 50 worldwide product approvals, and more than 100 INDs.
