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Hungary CBD Regulatory Market Report 2022 – ResearchAndMarkets.com


GREENWOOD VILLAGE, Colorado and NEW YORK–()–ANANDA Scientific Inc., a biotechnology pharmaceutical company, and NYU Grossman School of Medicine announced today that the first patient has been enrolled in a clinical trial evaluating Nantheia™ A1002N5San experimental drug using cannabidiol in the exclusive property of ANANDA Liquid Structure™ delivery technology. This test assesses Nantheia™ A1002N5S for opioid sparing in the treatment of participants with radiculopathic pain syndromes.

This trial is being conducted at NYU Grossman School of Medicine, led by Stephen Ross, MD, associate professor of psychiatry. Funding for this trial comes from the National Institute of Drug Abuse (NIDA), with additional support from ANANDA. NYU Grossman School of Medicine is #2 in the nation for research in 2022 US News and World Report Ranking of the “best doctoral schools”.

“We are thrilled to initiate this important trial and expand research into therapeutic alternatives to opioid drug therapies,” said Dr. Ross. “This research protocol creates an opportunity for the possible development of evidence-based CBD medicines to reduce opioid use and pain.”

“We are very pleased to continue our collaboration with NYU Grossman School of Medicine. We are impressed with the scientific rigor and professionalism of the NYU team in establishing a state-of-the-art program to test the efficacy of this very promising drug,” said Sohail R. ZaidiANANDA CEO. “The initiation of patient enrollment in this study is an important step in efforts to provide patients with radiculopathic pain with an alternative to the use of opioids for pain management.”

This is a randomized, double-blind, placebo-controlled trial with 40 participants receiving four months of treatment with Nantheia™ A1002N5S, or placebo with a follow-up after 2 months. The main measure of effectiveness is a change in the maintenance dose of opioids between the start and the end of the treatment period. The safety and tolerability of CBD will also be assessed throughout the trial. (ClinicalTrials.gov ID: NCT04760613).

ABOUT NANTHEIA™ A1002N5S

Nantheia™ A1002N5S is an investigational drug that uses CBD in ANANDA’s proprietary liquid structure delivery technology. Preclinical and initial clinical studies show that ANANDA’s Liquid Structure™ delivery technology (under license from Lyotropic Delivery Systems (LDS) Ltd. in Jerusalem, Israel) improves the efficacy and stability of CBD. Nantheia™ A1002N5S is an oral product containing 50mg of CBD per softgel.

ABOUT ANANDA SCIENTIFIC

ANANDA is a leading research-driven biotechnology company pioneering high-calibre clinical studies evaluating therapeutic indications such as PTSD, Radiculopathy painAnxiety and Opioid use disorder (Mount Sinai, UCLA). The company uses patented delivery technology to make cannabinoids and other plant-derived compounds highly bioavailable, water-soluble, and shelf-stable and focuses on producing high-quality, effective pharmaceutical products. In line with its strong research-based data, the company also has a growing pipeline of over-the-counter nutraceuticals. The company has successfully launched these products in the United States, Australia and the United Kingdom, with planned expansion into other markets such as the EU, China, Africa and other countries in Asia. . The company is expanding its research base through multiple sponsored research agreements with universities to diversify its technology portfolio.

ABOUT OPIOID SAVING FOR PATIENTS WITH CHRONIC NON-CANCER RADICULOPATHY

Chronic pain (pain that lasts 3 months or more) (1) is a widespread public health problem (2) (3) and is the greatest economic burden of any medical condition (4). Among chronic noncancer pain (CNCP) conditions, radicular pain disorders (particularly low back pain) have particularly high rates of opioid prescription (5), and higher opioid doses predict poorer outcomes. functional outcomes in this cohort of patients with chronic pain (6) . Estimates of the prevalence of opioid use disorder (OUD) in CNCP range from 5% in one meta-analysis (7) to 20-35% (8), (9), (10), (11). Despite all of this, the prescription of chronic opioid therapy (COT) for CNCP increased dramatically between 1990 and 2010, and is one of the root causes of the current opioid epidemic (12). Our goal is to develop an intervention to reduce opioid use in patients with CNCP root syndromes receiving moderate to high dose TOC at safer doses while maintaining or improving pain management.

THE REFERENCES

1. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain – United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49. Epub 2016/03/18. doi: 10.15585/mmwr.rr6501e1. PubMed PM ID: 26987082.

2. Nahin RL. Estimates of Pain Prevalence and Severity in Adults: United States, 2012. The Journal of Pain: Official Journal of the American Pain Society. 2015;16(8):769-80. Epub 2015/06/02. doi: 10.1016/j.jpain.2015.05.002. PubMed PMID: 26028573; PMCID: PMC4562413.

3. Institute of Medicine Committee on Advancing Pain Research C, Education. The National Academies Collection: Reports funded by the National Institutes of Health. Alleviating Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (USA), National Academy of Sciences; 2011.

4. Gaskin DJ, Richard P. The economic costs of pain in the United States. The Journal of Pain: Official Journal of the American Pain Society. 2012;13(8):715-24. Epub 2012/05/23. doi: 10.1016/j.jpain.2012.03.009. PubMed PMID: 22607834.

5. Webster BS, Verma SK, Gatchel RJ. Relationship between early opioid prescribing for acute occupational low back pain and duration of disability, medical costs, subsequent surgery, and late opioid use. Spine. 2007;32(19):2127-32. Epub 2007/09/01. doi: 10.1097/BRS.0b013e318145a731. PubMed PM ID: 17762815.

6. Kidner CL, Mayer TG, Gatchel RJ. Higher opioid doses predict poorer functional outcomes in patients with chronic disabling occupational musculoskeletal disorders. The Journal of Bone and Joint Surgery American Volume. 2009;91(4):919-27. Epub 2009/04/03. doi: 10.2106/jbjs.H.00286. PubMed PMID: 19339577; PMCID: PMC2665041.

7. Higgins C, Smith BH, Matthews K. Incidence of iatrogenic opioid dependence or abuse in patients with pain who have been exposed to opioid analgesic treatment: a systematic review and meta-analysis. Brother J Anaesth. 2018;120(6):1335-44. Epub 2018/05/26. doi: 10.1016/j.bja.2018.03.009. PubMed PMID: 29793599.

8. Sullivan MD, Von Korff M, Banta-Green C, Merrill JO, Saunders K. Issues and concerns of patients receiving chronic opioid therapy for chronic noncancer pain. Pain. 2010;149(2):345-53. Epub 2010/03/26. doi: 10.1016/j.pain.2010.02.037. PubMed PMID: 20334974; PMCID: PMC3318978.

9. Boscarino JA, Rukstalis M, Hoffman SN, Han JJ, Erlich PM, Gerhard GS, Stewart WF. Risk factors for substance abuse among outpatients on opioid treatment in a large US health care system. Dependency (Abingdon, England). 2010;105(10):1776-82. Epub 2010/08/18. doi: 10.1111/j.1360-0443.2010.03052.x. PubMed PMID: 20712819.

10. Juurlink DN, Dhalla IA. Dependence and addiction during chronic opioid treatment. Journal of medical toxicology: official journal of the American College of Medical Toxicology. 2012;8(4):393-9. Epub 2012/10/18. doi: 10.1007/s13181-012-0269-4. PubMed PMID: 23073725; PMCID: PMC3550262.

11. Boscarino JA, Hoffman SN, Han JJ. Opioid use disorder in patients on long-term opioid therapy: impact of DSM-5 final diagnostic criteria on prevalence and correlates. Addiction and rehabilitation. 2015;6:83-91. Epub 2015/09/01. doi: 10.2147/sar.S85667. PubMed PM ID: 26316838; PMCID: PMC4548725.

12. Vadivelu N, Kai AM, Kodumudi V, Sramcik J, Kaye AD. The Opioid Crisis: A Comprehensive Overview. Curr Pain Headache Rep. 2018;22(3):16. Epub 2018/02/25. doi: 10.1007/s11916-018-0670-z. PubMed PM ID: 29476358.



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