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January 4, 2021 – Orcosa is pleased to report the dosing of the first patient participating in an investigator-initiated multicenter Phase 1/2 clinical trial utilizing ORAVEXX™ at Baptist Health/Jacksonville Orthopaedic Institute (“JOI”).
The trial (NCT04672252), an investigator-initiated multicenter, randomized, double-blind, placebo-controlled clinical trial led by Principal Investigator Dr. Michael J. Alaia of NYU Langone Health Orthopedic Hospital (“NYU Langone”) and conducted in partnership with Baptist Health/Jacksonville Orthopaedic Institute, aims to evaluate the safety and impact on post-operative pain of cannabidiol (CBD) delivered utilizing Orcosa’s Rapid Infusion Technology (RITe™) Platform. The trial, which plans to enroll 100 patients undergoing arthroscopic rotator cuff repair, will also evaluate patient satisfaction and changes in opioid consumption over a 14-day postoperative period.
RITe™ tablets are fast-acting, easy-to-take tablets engineered to enhance drug absorption. ORAVEXX™ is a non-addictive proprietary cannabidiol composition that utilizes the RITe™ Platform to treat pain quickly and address the historical issues that CBD research has suffered, including inaccurate dosing, poor bioavailability, and difficult administration. ORAVEXX™ and its matching placebo contain no THC and have been made available to independent investigators seeking to conduct well-designed clinical research in accordance with FDA regulations.