Flexion's OA Knee Injection On Track For H2 Filing
This article was originally published in Scrip
Burlington, Mass.-based Flexion Therapeutics Inc.'s long-acting steroid injection Zilretta has been associated with statistically significant improvements in pain relief in a pivotal Phase III study in patients with knee osteoarthritis, countering disappointing results from a Phase IIb study reported last year and keeping the product in line for a US NDA submission in the second half on 2016.
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FDA labeling in knee pain osteoarthritis is favorable for long-acting steroid Zilretta and a sales force is lined up, but Flexion has its commercial work cut out competing with very cheap generics.
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Flexion CEO Mike Clayman shares expectations for Zilretta for knee osteoarthritis and discusses plans for commercialization in an interview at the Biotech Showcase in January.