Flexion Therapeutics announce results for Zilretta trials in osteoarthritis pain
Flexion Therapeutics has presented positive results from two pivotal clinical trials for its lead drug candidate, Zilretta, which show that the drug can provide sustained and significant pain relief in patients with moderate to severe osteoarthritis knee pain.
In the Phase III trial, Zilretta met its primary endpoint at week 12, demonstrating highly significant and clinically meaningful pain relief against placebo, as measured by the weekly mean of the average daily pain (ADP) score. It also showed significantly better outcomes in contrast to immediate-release triamcinolone acetonide (TCA).
In the Phase IIb trial, however, superiority in pain relief at 12 weeks did not reach statistical significance. Although, a pre-specified, commonly applied sensitivity analysis that addresses patient dropouts did demonstrate statistical significance for this primary endpoint at 12 weeks.
Professor Philip Conaghan, chair of musculoskeletal medicine at the University of Leeds, presented the results of these trials at the Osteoarthritis Research Society International (OARSI) 2016 World Congress in Amsterdam.
He comments: “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.”
Michael Clayman, president and CEO at Flexion Therapeutics, says: “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 osteoarthritis. In addition, we are especially gratified by the Phase III data that demonstrate clear differentiation of Zilretta from immediate-release TCA.
“Based on these data we have schedules a pre-New Drug Application meeting in May with the US Food and Drug Administration with the intent to gain the Agency’s endorsement to submit an NDA in the second half of 2016.”
German pharmaceutical company Grünenthal has announced that the US Food and Drug Administration (FDA) has …
Gilead has agreed to pay $97 million to resolve claims from the US Government that …