PleoPharma, 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 the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder.
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“We are pleased that PP-01 has been granted Fast Track designation and are grateful to the FDA for recognizing the significance of cannabis withdrawal for the growing population with cannabis use disorder,” said Ginger Constantine MD, CEO of PleoPharma.
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Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to patients earlier (FDA.gov). In addition, a drug candidate that receives Fast Track designation is eligible for more frequent meetings and written interactions with the FDA to discuss the drug candidate’s development plan as well as possible eligibility for rolling and priority reviews.
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Source – prnewswire
