PP-01 / PleoPharma - LARVOL DELTA

Proof-of-concept trial of PP-01 for mitigating cannabis withdrawal syndrome in participants with cannabis use disorder. (PubMed, Am J Addict) - "PP-01 is intended as a potential treatment for cannabis withdrawal syndrome (CWS)/CUD, a serious and unmet need for which there is no Food and Drug Administration (FDA)-approved medication."

Clinical • Journal • Substance Abuse

Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder (clinicaltrials.gov) - P3 | N=420 | Recruiting | Sponsor: PleoPharma, Inc.

New P3 trial • Substance Abuse

PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use (CPDD 2025) - No abstract available

Medication Development for Cannabis Use Disorder and Cannabis Withdrawal (CPDD 2025) - "First, a 12-week randomized controlled trial found significant reductions in cannabis use outcomes with varenicline treatment combined with medical management compared to placebo treatment...Second, treatment-seeking youth with CUD were randomized to receive a double-blind 12-week course of oral N-acetylcysteine (NAC) 1200 mg or placebo twice daily; all received weekly medical management and brief behavioral counseling. No difference in cannabis use reduction or cessation outcomes was noted between participants in the NAC and placebo groups, suggesting that NAC is not efficacious for youth CUD when not paired with contingency management. Finally, a phase 2 randomized multi-center double-blind, multiple dose, placebo-controlled clinical trial demonstrated that a unique 34-day taper/titration with nabilone and gabapentin (PP-01) significantly mitigated withdrawal symptoms and decreased cannabis use compared to placebo in adults with moderate to severe CUD seeking to..."

Substance Abuse

Predictors of Cannabis Abstinence in a Clinical Trial (CPDD 2025) - "Adult participants with moderate/severe CUD, a history of withdrawal, and seeking to discontinue cannabis were randomized to tapering/titrating doses of PP-01 high dose (HD), PP-01 low dose, nabilone, gabapentin, or placebo. More PP-01 HD participants reported no cannabis use compared to placebo. Early mitigation of withdrawal symptoms was predictive of cannabis abstinence including during the 2-week post-treatment period in this Phase 2 trial. Treating cannabis withdrawal symptoms may help to minimize recidivism."

Clinical

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 (PRNewswire) - "PleoPharma, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder."

Fast track • Substance Abuse

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 (PRNewswire) - "PleoPharma, Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder."

Fast track • CNS Disorders

Effect of PP-01 on Cannabis Withdrawal Syndrome (clinicaltrials.gov) - P2 | N=234 | Completed | Sponsor: PleoPharma, Inc. | Active, not recruiting ➔ Completed

Trial completion

Effect of PP-01 on Cannabis Withdrawal Syndrome (clinicaltrials.gov) - P2 | N=225 | Active, not recruiting | Sponsor: PleoPharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed

Effect of PP-01 on Cannabis Withdrawal Syndrome (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: PleoPharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Effect of PP-01 on Cannabis Withdrawal Syndrome (clinicaltrials.gov) - P2 | N=225 | Not yet recruiting | Sponsor: PleoPharma, Inc.

New P2 trial