One-year study adds reassuring follow-up data for ORC-144

Orcosa announced the publication of one-year follow-up results from the clinical trial evaluating ORC-144 after arthroscopic rotator cuff repair. Published in the Orthopaedic Journal of Sports Medicine, the study adds a longer-term perspective to the encouraging early pain-control findings reported in 2022.

The follow-up addressed an important question for postoperative care: after a medicine is used to help manage pain in the first days following surgery, how are patients doing a year later? Researchers obtained follow-up from 83 of the 99 patients who completed the original randomized trial. Treatment with ORC-144 or placebo had lasted 14 days after surgery; the one-year assessment measured subsequent outcomes.

At follow-up, the groups showed no statistically significant differences in pain, satisfaction, or the patient-reported shoulder measures assessed. Those measures included the American Shoulder and Elbow Surgeons score and Single Assessment Numeric Evaluation, which capture patients’ experience of shoulder function and recovery.

The findings are reassuring: investigators detected no disadvantage in these longer-term outcomes among patients who had received the short course of ORC-144. They add to the clinical evidence supporting continued investigation of the tablet for postoperative pain, while providing useful information about recovery beyond the initial treatment period.

The original trial was led by Michael J. Alaia, MD, with researchers from NYU Langone Health and Baptist Health/Jacksonville Orthopaedic Institute. It reported lower pain on the first postoperative day and greater satisfaction with pain control on days one and two among patients receiving ORC-144 compared with placebo.

ORC-144 (formerly coded ORAVEXX) is Orcosa’s investigational CBD tablet, developed using the RITe™ Platform. It has not been approved by the FDA.