Of 45 patients treated, 84.4% responded with both a reduction in joint pain and an improvement in knee function.
Patients’ self-reported pain scores were reduced by 50% on average from baseline pain scores in 45 patients with knee osteoarthritis and concurrent bone marrow lesions.
In January, a European patent was granted for the treatment of bone marrow edema lesions with PPS.
Results represent improvement on opioid treatments
The patients were treated by their doctor with injectable PPS under the Therapeutic Goods Administration’s Special Access Scheme (SAS).
The 50% reduction in pain scores observed with PPS in knee osteoarthritis is significant in relative terms.
It demonstrates superiority over the independently reported 15% pain reduction scores for opioid treatments for chronic pain in osteoarthritis of the knee and hip.
Fits criteria of clinically meaningful pain reduction
The comparative effects of PPS therapy against opioid treatments implies that the data provides evidence of clinically meaningful improvements in chronic pain.
Clinically meaningful reduction of chronic pain has been defined to be between 25-30% pain reduction by an independent source.
These results precede the read-out from Paradigm’s phase IIb randomised, double-blind, placebo-controlled, multicentre, clinical trial, which is expected in the fourth quarter.
By that stage the phase IIb clinical trial data will be supplemented with an additional 150 patients.