PleoPharma Begins Phase 3 Trial for Cannabis Withdrawal Medication

The CAN-004 study is a multicenter, randomized, double-blind trial designed to evaluate the safety and efficacy of PP-01 in adults with moderate to severe cannabis use disorder. The drug features a dual mechanism of action, targeting both suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. By providing a once-daily treatment option, the company hopes to offer a viable path for patients attempting to discontinue cannabis use.

Ginger Constantine, CEO and co-founder of the Phoenixville-based firm, noted that despite the high prevalence of the disorder, no FDA-approved medications currently exist to manage withdrawal syndrome. The clinical program builds on positive Phase 2b data and is intended to provide the necessary evidence to support a new drug application. With over 1.4 million people seeking treatment in 2024 without the benefit of medication-assisted options, the success of this trial could mark a significant shift in addiction medicine.