Landmark ORC-144 clinical trial results published in AJSM

Orcosa announced the publication of positive clinical trial results for ORC-144 in The American Journal of Sports Medicine (AJSM). The study evaluated Orcosa’s investigational cannabidiol (CBD) tablet in patients recovering from arthroscopic rotator cuff repair, marking an important milestone for the company’s lead program and RITe™ Platform.

Led by Michael J. Alaia, MD, of NYU Langone Health, with researchers at Baptist Health/Jacksonville Orthopaedic Institute, the multicenter study included 99 patients. Participants were randomly assigned to receive ORC-144 or an identical placebo three times daily for 14 days after surgery. Patients and treating physicians were blinded to treatment assignment, and both groups had access to prescribed rescue pain medication.

On the first day after surgery, patients receiving ORC-144 reported an average of 23% less pain than those receiving placebo. Satisfaction with pain control was also higher in the ORC-144 group—by approximately 22% to 25% on the first and second postoperative days. These differences were statistically significant at the respective time points.

The investigators reported an acceptable safety profile during the study, with no significant differences between groups in postoperative liver function tests. NYU’s announcement reported no major side effects.

Described by NYU as among the first clinical studies of its kind, the research brought a controlled evaluation of a specifically developed pharmaceutical formulation to an area with limited clinical evidence. ORC-144 (formerly coded ORAVEXX) was designed and manufactured by Orcosa; the findings relate to that investigational tablet.

Publication in AJSM provides a peer-reviewed foundation for further research into ORC-144 as a potential option for acute pain. ORC-144 remains investigational and has not been approved by the FDA.