FDA Fast Tracks PP-01: A Breakthrough for Cannabis Use Disorder

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PleoPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, an investigational treatment for cannabis withdrawal syndrome in patients with cannabis use disorder (CUD).

The designation highlights the urgent need for effective therapies in a growing population, as approximately 19.2 million Americans were affected by CUD in 2023, with 1.64 million receiving treatment. Treatment rates for cannabis-related health problems have been rising by 27% annually since 2018.

Fast Track status — which is granted for new drugs that treat serious medical conditions and fill an unmet medical need — will allow PleoPharma to accelerate the development and review processes. This designation also opens the door for priority and rolling reviews, potentially expediting patient access to PP-01.

Currently, no FDA-approved medications exist for treating cannabis withdrawal or CUD, reinforcing the need for innovative solutions like PP-01.

PP-01 is a first-in-class, dual-mechanism investigational therapy that targets CB1 receptor suppression and neurotransmitter dysregulation in the brain’s reward pathway.

The once-daily oral treatment aims to provide a rapid-onset, well-tolerated option for those struggling with withdrawal symptoms, such as insomnia, anxiety, irritability and depressed mood.

“We recognize that many people do use cannabis without becoming dependent,” said Ginger Constantine, M.D., CEO of PleoPharma, “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.”

With the rising demand for treatment and no existing pharmaceutical options for either CUD or cannabis withdrawal syndrome, PleoPharma’s advancement of PP-01, which is currently entering a phase 3 clinical trial, could mark a major milestone in addressing cannabis-related health concerns.