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FDA Grants Fast Track Designation to PleoPharma's PP-01 for Cannabis Withdrawal Syndrome

Summary by MyChesCo
PHOENIXVILLE, PA — PleoPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, the company’s lead investigational asset aimed at mitigating Cannabis Withdrawal Syndrome in patients suffering from Cannabis Use Disorder (CUD). This milestone signifies an important step forward in addressing a critical and growing unmet medical need. Recognizing an Urgent Public Health Challenge Canna…
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MyChesCoMyChesCo

FDA Grants Fast Track Designation to PleoPharma's PP-01 for Cannabis Withdrawal Syndrome

PHOENIXVILLE, PA — PleoPharma, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, the company’s lead investigational asset aimed at mitigating Cannabis Withdrawal Syndrome in patients suffering from Cannabis Use Disorder (CUD). This milestone signifies an important step forward in addressing a critical and growing unmet medical need. Recognizing an Urgent Public Health Challenge Canna…

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Pharmacy TimesPharmacy Times

Potential Drug for Mitigation of Cannabis Withdrawal Symptoms Receives FDA Fast Track Designation

PP-01 could become a first-in-class treatment for patients with cannabis use disorder.

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pressreach.compressreach.com

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 - PressReach

Fast Track Designation highlights the potential of PP-01 to address a serious and unmet need for patients with Cannabis Use Disorder Phase 3 Preparations Underway PHOENIXVILLE, Pa., Feb. 13, 2025 /PRNewswire/ — PleoPharma, Inc., a privately held company focused on finding treatments for cannabis related health issues, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PP-01, its lead asset, for…

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drugtopics.comdrugtopics.com

FDA Grants Fast Track Designation to Cannabis Withdrawal Syndrome Therapy

A dose response is observed with the highest dose of the drug and mitigating withdrawal symptoms for patients with cannabis use disorder.

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drugtopics.com broke the news in on Thursday, February 13, 2025.
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