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- PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at The College on Problems of Drug Dependence Annual Meeting
Positive Phase 2b Results from the CAN-002 Study of PP-01, an investigational product intended to mitigate Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder PHOENIXVILLE, Pa., June 19, 2025 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 2b multicenter, randomized, double-blind, multi-dose, placebo-controlled clinical trial of titrating doses of PP-01 for the mitigation of Cannabis Withdrawal Syndrome (CWS) in participants with Cannabis Use Disorder (CUD) at the 2025 annual meeting of The College on Problems of Drug Dependence in New Orleans, LA. PleoPharma, Inc. presented both a poster presentation "Predictors of Cannabis Abstinence in a Clinical Trial" on June 17, 2025 and an oral presentation "PP-01 Significantly Mitigated Cannabis Withdrawal Symptoms with a Decrease in Cannabis Use" on June 18, 2025 from their Phase 2b study data. This study evaluated the safety and effectiveness of PP-01, a novel once daily, oral, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. Adult treatment-seeking participants in the CAN-002 Study reported average baseline cannabis use of 4.6 grams/day and mean age of first use ~16.5 years (range 7 to 46). By DSM-5 criteria, 84% had severe CUD and 16% had moderate CUD. PP-01 significantly reduced Cannabis Withdrawal Scores compared to placebo (P value < 0.02). A secondary endpoint evaluated cannabis abstinence and PP-01 demonstrated 5-fold greater abstinence two weeks post-treatment compared to placebo. Data also showed that reduction of cannabis withdrawal symptoms during the first week of treatment was predictive of abstinence. PP-01 was well tolerated. The most common adverse events were mild and included headache, somnolence, fatigue, nausea, and dizziness. There were no serious adverse events. "We are excited to be developing PP-01, which was granted Fast Track designation by the FDA, and has the potential to be the first FDA approved product to help people suffering from CWS with CUD, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. SOURCE PleoPharma, Inc See this Press Release on PR Newswire
- PLEOPHARMA, INC. Reports New Patent Issuance
New Patent Issued on April 8, 2025 Patent Protection to March 2041 PHOENIXVILLE, Pa., April 16, 2025 /PRNewswire/ -- PleoPharma, Inc. ("PleoPharma" or the "Company"), a privately held company focused on Cannabis-related health issues, announced today that the U.S. Patent Office has issued a new patent focusing on the treatment of sleep disturbances, including sleep quality and duration, associated with cannabis withdrawal syndrome ("CWS") in patients with cannabis use disorder ("CUD"). " We are pleased to have received our third issued patent. Improving sleep quality, depth and duration for patients suffering from CWS is an important aspect of PP-01 and a tremendous benefit in quality of life, especially for CUD patients who are suffering from CWS," said PleoPharma's CEO, Ginger Constantine, MD. Recently issued U.S. Patent No. 12,268,659 , entitled "Methods and Compositions for Treating Cannabis Use Disorder and Mitigating Cannabinoid Withdrawal," contains method of use claims for mitigating CWS, and in particular improving sleep quality, depth and duration, and further claiming specific dose ranges and detailed dosing schedules corresponding to what the Company believes will be the dosing for PP-01. The Company notes that additional patent applications are pending in the US and globally in which it is pursuing further IP development. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with ~ 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms, known as Cannabis Withdrawal Syndrome, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma recognizes that many people do use cannabis responsibly, but as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. See this Press Release on PR Newswire
- PLEOPHARMA, INC. Presents Positive Cannabis Withdrawal Clinical Trial Results at AAAP Annual Meeting
Pharmacodynamic Results from the CAN-001 Phase 1b Study of PP-01, an Investigational Product, intended to Mitigate Cannabis Withdrawal Syndrome PHOENIXVILLE, Pa., Nov. 18, 2024 /PRNewswire/ -- PleoPharma, Inc., a privately held company focused on cannabis-related health issues, announced today, the presentation of data from their Phase 1b Pharmacokinetic and Pharmacodynamic study of Cannabis Withdrawal Syndrome ("CWS") in participants with Cannabis Use Disorder ("CUD") at the annual meeting of the American Academy of Addiction Psychiatry (AAAP) in Naples, Fla. "We are pleased to present our proof-of-concept study that evaluated the safety and effectiveness of PP-01, a novel, dual-mechanism investigational agent containing tapering and titrating doses of nabilone and gabapentin in mitigating cannabis withdrawal symptoms in participants with moderate to severe CUD. We are excited to be developing PP-01 with the goal of being the first FDA approved product to help people suffering from CWS, a rapidly growing patient population in need of treatment. We are currently preparing for PP-01 to enter Phase 3", stated Shelli Graham, PhD, Senior Vice-President of Medical/Clinical Research. Participants in the CAN-001 Study reported using an average of 3.5 ± 2.2 grams/day of cannabis with a mean age of first use 14 years (range 6 to 22). By DSM-5 criteria, 64% had severe CUD and 36% had moderate CUD. Compared to placebo, PP-01 administered once daily significantly reduced mean CWS ratings beginning 4 hours post first dose of PP-01 (first measured timepoint). This effect was sustained through Day 5 ( P values < 0.0009; all timepoints). Participants experienced fewer cravings, better sleep and were also less bothered by their withdrawal symptoms when treated with PP-01 than with placebo ( P values < 0.007; all timepoints). PP-01 was well tolerated. There were no serious adverse events, and all adverse events in the PP-01 group were mild in severity. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had CUD with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with CUD commonly experience significant withdrawal symptoms, known as CWS, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of CWS or CUD. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of CWS in people with CUD. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire Click below to download a copy of the poster presented at the November 18, 2024 AAAP Meeting:
- 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 TREATMENT 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 the mitigation of Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder. "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. 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. About cannabis withdrawal/cannabis use disorder The US Government (SAMHSA) reported that in 2023, ~19.2 million Americans had cannabis use disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The reported number of individuals who received treatment for cannabis related health problems has grown by an average of 27% annually from 2018 to 2023 ( samhsa.gov ) . People with cannabis use disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of either cannabis withdrawal syndrome or cannabis use disorder. "We recognize that many people do use cannabis without becoming dependent", said Ginger Constantine, "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." About PP-01 PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is entering a Phase 3 clinical trial and has the potential to be the first-in-class treatment to mitigate the withdrawal syndrome experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended to be a once daily oral product with a rapid onset of action and an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space focused on finding solutions for people suffering from cannabis addiction and other cannabis related health problems. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma Inc., please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire
- PLEOPHARMA, INC. Strengthens Patent Portfolio with Issuance of Two U.S. Patents
2nd Patent issued in September 2024 Patent Protection to March 2041 PHOENIXVILLE, Pa., Oct. 7, 2024 /PRNewswire/ -- PleoPharma, Inc. ("PleoPharma" or the "Company), a privately held company focused on Cannabis-related health issues, announced today that it has been issued two U.S. patents with broad claims relating to methods of treating cannabis withdrawal syndrome ("CWS"). " We are pleased to have received the issuance of our second patent following up on the success of our Phase 2b trial. These U.S. patent issuances underscore the scientific achievements of PleoPharma and directly support the commercial value of our programs" said Ginger Constantine, CEO of PleoPharma. "We are excited to be developing PP-01 with the goal of being the first approved product to help people suffering from CWS, a rapidly growing patient population". U.S. Patent 11,197,846 and U.S. Patent 11,931,334 , both entitled "Methods and Compositions for Treating Cannabis Use Disorder and Mitigating Cannabinoid Withdrawal," contain method of use claims for mitigating CWS drawn to specific dose ranges and detailed dosing schedules corresponding to what the Company believes will be the dosing for PP-01. The Company notes that additional patent applications are pending in the US and globally in which it is pursuing further IP development. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms, known as Cannabis Withdrawal Syndrome, that can make it extremely difficult to reduce or discontinue cannabis. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma recognizes that many people do use cannabis responsibly, but as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire
- PLEOPHARMA, INC. PARTICIPATES IN THE LIFE SCIENCES PA'S LIFE SCIENCE FUTURE CONFERENCE
PHOENIXVILLE, Pa., Sept. 19, 2024 -- PleoPharma, Inc., a privately held company focused on cannabis related health issues, announced today that their CEO, Ginger Constantine, MD, presented at the Life Sciences PA's Life Sciences Future Conference. Dr. Constantine presented data from PleoPharma's Phase 1 and Phase 2b studies of PP-01, their lead drug candidate intended for the mitigation of Cannabis Withdrawal Syndrome. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who have received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with regular and dependent cannabis use commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. About PP-01 PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is an investigational product entering Phase 3 that is in development for the mitigation of symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset that is being developed as the first FDA approved treatment for mitigation of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder.The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. CONTACT: dhalkuff@pleopharma.com See this Press Release on PR Newswire
- PleoPharma Inc. Completed a $17.5 Million Series A Financing Funding a Phase 2b Study for Cannabis Addiction and Withdrawal
June 2023 PleoPharma Inc, announces it completed a Series A financing of $17.5 Million led by DynaGrow Capital, MintPharma Capital and 8 current and former CEOs from Large, Mid and Small CAP Biotech companies in June of 2023. PleoPharma used the proceeds to complete a Phase 2b study of PP-01 for the mitigation of cannabis withdrawal syndrome in participants with cannabis use disorder. The US Government reported that in 2023 ( 2023 NSDUH Detailed Tables | CBHSQ Data ( samhsa.gov ) ), ~19.2 million Americans had cannabis use disorder and 1.64 million people received treatment for cannabis addiction (~500k inpatient and ~1.1 million outpatient). The number of people receiving treatment for cannabis grew by 23% from 2022 to 2023 and by an average of 28% per year since 2018. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. PleoPharma believes that while many people use cannabis responsibly, as with alcohol, a minority may develop dependence. PleoPharma’s mission is to provide a treatment option for those who want help reducing or discontinuing cannabis. The first FDA approved medication assisted therapy (MAT) for the treatment of cannabis addiction / withdrawal (PP-01) should enable an optimal outpatient solution for patients while at the same time significantly reducing the current cost of care. “I am honored and grateful to our seasoned pharma execs and investors for having advanced PleoPharma’s mission to develop a product for this growing unmet need”,” said Ginger Constantine, MD, CEO PleoPharma Inc. “ About PP-01 PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway.PP-01 is an investigational product entering Phase 3 that is being developed to mitigate symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs.
- PLEOPHARMA, INC. REPORTS POSITIVE PHASE 2b CLINICAL TRIAL DATA FOR MITIGATION OF CANNABIS WITHDRAWAL: A POTENTIAL FIRST IN CLASS TREATMENT
Phase 2b Study for PP-01 Met Its Primary Endpoint End of Phase 2 Meeting with FDA Completed Phase 3 Preparations Underway PHOENIXVILLE, Pa., Sept. 5, 2024 -- PleoPharma, Inc., a privately held company focused on cannabis related health issues, announced today Phase 2b study results for its lead drug candidate, PP-01, an investigational product intended for the mitigation of Cannabis Withdrawal Syndrome. Phase 2b Study (CAN-002) CAN-002 was a randomized, double-blind, placebo-controlled study with 234 participants between ages 18-55, seeking to discontinue cannabis, at 22 US addiction centers. Participants in the study demonstrated statistically significant reductions in cannabis withdrawal symptoms with PP-01 vs. Placebo. A dose response was observed with the highest dose providing mitigation of withdrawal symptoms with clinically meaningful results (primary endpoint p =0.02). PP-01 was well tolerated and without a safety signal. Phase 3 planning continues in conjunction with FDA input following a recently completed End of Phase 2 FDA meeting. About cannabis withdrawal/cannabis use disorder The US Government reported that in 2023 ( samhsa.gov ) , ~19.2 million Americans had Cannabis Use Disorder with 1.64 million people receiving treatment (~500k inpatient, ~1.1 million outpatient). The number of individuals who received treatment for cannabis related health problems has grown by an average of 28% annually from 2018 to 2023. People with Cannabis Use Disorder commonly experience significant withdrawal symptoms. There are currently no FDA approved medications for the treatment of cannabis withdrawal syndrome or cannabis use disorder. "The completed Phase 1 and Phase 2 studies demonstrate that PP-01 has the potential to help those who suffer from cannabis withdrawal when attempting to discontinue cannabis," said Ginger Constantine, MD, CEO PleoPharma." We recognize that many people do use cannabis responsibly but, as with alcohol, some may develop a dependence. Our mission is to provide a treatment option for those who want help reducing or discontinuing cannabis." About PP-01 PP-01 has a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway.PP-01 is an investigational product entering Phase 3 that is being developed to mitigate symptoms related to cannabis withdrawal. PP-01 is intended to be a once daily oral product taken before bedtime providing rapid and sustained efficacy with an excellent safety and tolerability profile. About PleoPharma, Inc. PleoPharma, Inc. is a clinical stage development company in the neuropsych and addiction space with a lead asset, PP-01, that is being developed as the first FDA approved treatment of Cannabis Withdrawal Syndrome in people with Cannabis Use Disorder. The PleoPharma team includes a world class management team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs. For more information on PleoPharma, please visit www.PleoPharma.com or email Dawn Halkuff, head of Investor Relations at dhalkuff@pleopharma.com . This release includes 'forward-looking statements' regarding the operations of PleoPharma, Inc., actual results may differ from its expectations, estimates, and projections and, consequently, you should not rely on these forward-looking statements as predictions of future events. All statements other than statements of historical facts contained herein are forward-looking statements that reflect the current beliefs and expectations of management of PleoPharma. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from those discussed in the forward-looking statements. PleoPharma does not undertake or accept any obligation or undertaking to release any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. See this Press Release on PR Newswire