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Paradigm's IND application to commence its phase 3 pivotal clinical trial investigating Pentosan Polysulphate Sodium (PPS) for the treatment of pain associated with knee osteoarthritis has been cleared by the US FDA. Approximately 65 sites have been identified throughout the US and Australia. Contracting with many of those sites has been completed.
In October 2017 Zilretta was approved by the FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain. [6] In December 2017, Flexion acquired an investigational gene therapy product candidate for the treatment of osteoarthritis (OA), known as FX201. [7]
In osteoarthritis, there is a loss of articular hyaluronic acid activity, likely contributing to pain and stiffness associated with the condition. Hyaluronic acid injections are an FDA-approved treatment for osteoarthritis of the knee, and are sometimes also used for other joints. However, the merits of HA injections are still disputed.
Rofecoxib was approved by the FDA to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea. When it was marketed, it gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain. [1]
Three phase III clinical trials led by NicOx have shown that naproxcinod was effective to treat pain against knee osteoarthritis [6] [7] [8] and hip osteoarthritis. [9] A phase II study showed no significant differences in efficacy between naproxcinod and the COX-2 inhibitor rofecoxib in the treatment of pain. [10]
Two FDA advisory committees will begin meeting Wednesday on a Pfizer drug called tanezumab that could bring relief for osteoarthritis pain. FDA advisory committees will begin hearings on drug ...
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