Results from two pivotal clinical trials sponsored by Flexion Therapeutics, Inc. show that its drug candidate Zilretta provided “sustained and significant pain relief in patients with moderate to severe osteoarthritis (OA) knee pain, ” according to the April 4, 2016 news release. Professor Philip Conaghan, M.B., B.S., Ph.D., F.R.A.C.P., F.R.C.P., Chair of Musculoskeletal Medicine at the University of Leeds, said, “Consistent results across two pivotal clinical trials with Zilretta suggest that, at last, we have a long-lasting intra-articular therapy that is highly effective and has the potential to change the treatment paradigm for osteoarthritis.”
“We are delighted to be able to now share the detailed data from these studies which clearly demonstrate clinically meaningful and statistically significant pain relief in patients with knee OA. In addition, we are especially gratified by the Phase 3 data that demonstrate clear differentiation of Zilretta from immediate-release TCA [triamcinolone acetonide], ” said Michael Clayman, M.D., Flexion Therapeutics’ President and CEO. “Based on these data we have scheduled a pre-New Drug Application (NDA) meeting in May with the U.S. Food and Drug Administration (FDA) with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”
Asked about the clinical data, Dr. Clayman told OTW, “To date we have completed two pivotal studies (Phase 2b and Phase 3) and have seen strikingly similar results that show statistically significant pain relief among patients with osteoarthritis of the knee who were treated with Zilretta compared to those who received placebo. These consistent results demonstrate both the magnitude of pain relief with Zilretta as well as the durability of relief as measured over the 12-week study period and beyond. In addition, patients who received Zilretta reported significant improvements on several measures of daily function, which really matter to patients.”
“There have been no new advances in treating osteoarthritis of the knee in nearly a decade, and a majority of patients are not satisfied with their current therapy. Zilretta has the potential to fill this treatment gap by relieving pain locally because it is specifically designed to prolong the duration of pain relief with its slow-release mechanism of action. In addition, Zilretta relieves pain without the risks associated with current therapies, which include opioids that have addictive liabilities.”
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