Of the 75 patients, 84% responded with both a reduction in joint pain and an improvement in knee function.
Notably, patients’ self-reported pain scores were reduced over 50% on average from baseline pain scores.
Superior to 15% pain reduction from opioid treatments
The maintained 50% average reduction in pain scores, observed with PPS in knee osteoarthritis, continues to demonstrate superiority over the opioid treatment alternative.
Historical data previously showed 15% pain reduction scores for opioid treatments for chronic pain in osteoarthritis of the knee and hip.
Real world data support ongoing clinical trials
These patients were treated under a similar dosing regimen as Paradigm’s current phase IIb osteoarthritis clinical trial, which is expected to release results in the coming December quarter.
The results from these 75 patients provide important real world evidence data, which can be used in combination with clinical trials to support product registration.
Paradigm will continue to report over the coming months on the groups of patients that are currently undergoing treatment from their doctors under the TGA Special Access Scheme (SAS).
Number of patients seeking treatment accelerating
Paradigm’s CEO Paul Rennie said: “The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment.
“Furthermore, it is a significant positive outcome that all these patients have on average, a clinically meaningful reduction in pain of 50%.
“Given these patients have a very similar treatment regimen to subjects being treated under the current phase IIb osteoarthritis randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we feel particularly confident regarding a positive clinical trial outcome, with the expected release of headline results for that trial due in Q4 CY 2018.”