CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cytel Inc., a global provider of clinical research services and software, congratulates its client Flexion Therapeutics, Inc. on the release of Phase 3 data for its lead drug candidate Zilretta (also known as FX006). It was announced in February that the Phase 3 clinical trial met its primary endpoint at week 12, demonstrating highly significant (p<0.0001), durable and clinically meaningful pain relief against placebo in patients with moderate to severe osteoarthritis (OA) knee pain.
Cytel delivered statistical design, analysis and reporting services for the Phase 3 double-blind placebo-controlled, active-comparator trial.
Senior Vice President at Cytel, Irving Dark said, “We commend our client Flexion Therapeutics on these promising data from the Phase 3 trial. Expert statistical design and analysis are critical to the successful delivery of clinical studies, and we are delighted to have been able to provide support in this capacity.”
Zilretta achieved statistically significant analgesia against placebo at weeks 1 through 16 and patients treated with Zilretta experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12. In pre-specified analyses, Zilretta achieved statistical significance against placebo in validated OA and quality of life secondary measures through week 12.
Cytel continues to provide expert statistical and medical writing support to Flexion Therapeutics as it prepares for a potential NDA submission of Zilretta.
Cytel are shaping the future of drug development. Widely regarded for pioneering work in adaptive clinical trials, Cytel leverage their statistical expertise towards cutting-edge trial design and implementation software. As the world’s leading biometrics CRO, the company help sponsor companies of all sizes to improve their clinical research success rates.