The randomised double-blind placebo-controlled trial aims to evaluate the effect of iPPS on knee pain in participants with knee osteoarthritis and subchondral bone marrow lesions.
The company expects to report the results of the pivotal phase IIb clinical trial by late in the December quarter 2018.
Paradigm’s CEO Paul Rennie said: “The Paradigm clinical and regulatory team along with all the clinical trial recruitment and treatment centres have done an extraordinary job to conclude the recruitment of this phase II clinical trial in just over 7 months.
"What further underlines the outstanding job is the Paradigm’s second phase IIa clinical study (Ross River virus) is also nearing completion of recruitment.”
No adequate pain relief available
The iPPS has the potential to be a break-through in the treatment of osteoarthritis, where current therapies do not have adequate pain-relieving effects and are associated with adverse side effects.
Demand for an effective non-addictive alternative pain treatment has been amplified by the opioid epidemic in the US.
US FDA supporting new pain treatments
The US Food and Drug Administration (FDA) is taking steps to address the many facets of the complex opioid public health crisis.
Its goal is to support more rational prescribing practices, as well as identify and encourage development of new treatment options that don’t have the addictive features of opioids.