Cytel Congratulates Flexion Therapeutics on Release of Phase 3 Data for Zilretta

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.
About Cytel
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.