Source: Paradigm Biopharmaceuticals
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  • Paradigm Biopharmaceuticals (PAR) granted Fast Track Designation by the US Food and Drug Administration (FDA) for its phase-three osteoarthritis development program
  • The company’s planned phase-three clinical trial will investigate its pentosan polysulfate sodium (Zilosul) medication for the treatment of osteoarthritis
  • Paradigm says the FDA Fast Track program will help advance development and expedite the review of the Zilosul product
  • The Fast Track Designation provides Paradigm with the opportunity to interact and collaborate with the FDA more frequently during program development and potentially shorter review timelines
  • PAR shares 21.6 per cent higher at $1.41

The US Food and Drug Administration (FDA) has granted Paradigm Biopharmaceuticals (PAR) Fast Track Designation for its phase-three osteoarthritis development program.

Paradigm shares climbed following the announcement to the market.

The company’s planned phase-three clinical trial was designed to investigate its pentosan polysulfate sodium (Zilosul) medication for the treatment of osteoarthritis.

Paradigm said the FDA Fast Track program would help advance development of the Zilosul product and expedite the review of the therapy for the serious condition.

“This is welcome news from the US FDA as the company continues to gain momentum
in site activation and participant screening across the 56 selected sites in the US,” Paradigm Chief Medical Officer and interim CEO Dr Donna Skerrett said.

“Paradigm believes Zilosul would represent an important medical advance in the treatment of debilitating osteoarthritis pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”

The Fast Track Designation offers the company the opportunity to interact and collaborate with the FDA more frequently during program development and potentially shorter review timelines.

Paradigm was currently screening and enrolling participants in Australia and the US for the global phase three clinical trial, with sites in Europe, the UK and Canada to be initiated.

PAR shares were trading 21.6 per cent higher at $1.41 at 1:52 pm AEST.

PAR by the numbers
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