Cannabis Use Disorder: FDA Grants Fast Track Status to Investigational Agent PP-01
The development comes at a time when cannabis use disorder has risen steadily in the United States.
The US Food and Drug Administration (FDA) has granted Fast Track designation to PleoPharma Inc’s lead investigational agent, PP-01, intended to mitigate cannabis withdrawal syndrome in patients diagnosed with cannabis use disorder, according to a company news release.1
The designation is expected to streamline development and review, a critical step for an agent addressing a condition for which no FDA-approved treatments exist.
PP-01 is a once-daily oral product with a dual mechanism of action that targets both suppressed CB1 receptors and neurotransmitter dysregulation within the mesolimbic reward pathway. The investigational agent aims to reduce withdrawal symptoms that can perpetuate cannabis dependence. Phase 3 clinical trials are being planned.
"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, in a news release.1
Cannabis use disorder has risen steadily in the United States. The Substance Abuse and Mental Health Services Administration (SAMHSA) reported in 2023 that approximately 19.2 million Americans met criteria for cannabis use disorder, with 1.64 million receiving treatment—about one-third of whom required inpatient care.PP-01 is intended for individuals who seek help discontinuing cannabis.
Fast Track designation offers benefits such as frequent communication with the FDA and the potential for rolling review of a new drug application. PleoPharma officials say these regulatory advantages may accelerate the timeline for making PP-01 available to patients.
Reference
1. 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. PR Newswire. Published February 13, 2025. Accessed February 13, 2025. https://prnmedia.prnewswire.com/news-releases/fda-grants-fast-track-designation-to-pleopharma-incs-investigational-new-drug-pp-01-for-the-mitigation-of-cannabis-withdrawal-symptoms-in-patients-with-cannabis-use-disorder-a-potential-first-in-class-treatment-302376117.html
