Close up of hands of scientists dropping marijuana oil for experimentation and research.
Pharmaceutical development company PleoPharma has received a grant from the U.S. Federal Drug Administration to fast-track the development of a medication designed to mitigate cannabis withdrawal syndrome in patients with cannabis use disorder.
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, which is a new investigational drug for cannabis withdrawal syndrome.
If approved, this medication can help people with cannabis use disorder to overcome the withdrawal challenges by reducing its adverse effects.
What Is Cannabis Withdrawal Syndrome?
Cannabis withdrawal syndrome can be caused by abrupt reduction or cessation of cannabis consumption among chronic users.
This change can lead to irritability, anxiety, insomnia, loss of appetite, restlessness, and mood swings.
Though not potentially life-threatening, cannabis withdrawal syndrome makes quitting cannabis particularly hard and is an established characteristic of cannabis use disorder.
For example, some consumers of cannabis who stop use when the substance loses the same level of desired effect develop withdrawal symptoms similar to withdrawal.
Taking a T-break—a deliberate break from usual use aimed at reducing tolerance and ultimately heightening the experience when cannabis is resumed—is challenging.
During this break, most feel irritability, increased anxiety, mood swings, and insomnia. Though the aim is to recalibrate the body’s response to cannabis in the long term, the initial break period can be uncomfortable.
In 2023, The Substance Abuse and Mental Health Services Administration (SAMHSA) reported that about 19.2 million Americans had cannabis use disorder and that 1.64 million of them received treatment—about 500,000 inpatient and 1.1 million outpatient. From 2018 to 2023, the U.S. government agency responsible to the Department of Health and Human Services registered a 27% average increase yearly in individuals being treated for issues related to cannabis.
Despite withdrawal symptoms that are typically seen in people with cannabis use disorder, no FDA-approved medications exist today for the treatment of either cannabis withdrawal syndrome or the disorder.
How Does This Medication Treat Cannabis Withdrawl Syndrome?
PP-01, the investigational new drug from PleoPharma to mitigate cannabis withdrawal syndrome, is administered once daily at night. It has two mechanisms by which it works—one that targets CB1 receptors and another through which it balances neurotransmitters.
The treatment is now moving into Phase 3 clinical trials and may become the first option specifically designed to ease withdrawal symptoms in patients with cannabis use disorder.
Fast Track is an FDA initiative that accelerates drug development and review for drugs intended to treat serious diseases or unmet medical conditions, bringing patients to new treatments sooner. It also offers more frequent meetings with the FDA to simplify a drug’s development plan and can offer advantages like rolling and priority reviews.
The Phase 2b trial of PP‑01 reached its primary goal. Data indicated that the highest dose produced a clear dose‐response effect, significantly reducing withdrawal symptoms. This randomized, double‐blind, placebo‐controlled study—known as CAN‑002—enrolled 234 participants aged 18 to 55 who were seeking to stop cannabis use, and it was conducted at 22 centers across the United States. Additionally, PP‑01 was well tolerated, with no concerning safety signals observed.
PleoPharma said it would partner with the FDA on a Phase 3 trial.
While noting that the vast majority of those who consume cannabis are not dependent on it, Ginger Constantine, CEO of PleoPharma, said in a press statement that some may develop dependence “that may be sustained and worsened by withdrawal symptoms.”
