Positive data indicate that patients with unilateral knee OA pain treated with Zilretta experienced significant and sustained improvements in pain, function, and knee-related quality of life metrics.- Flexion Terpeutics.

Flexion Therapeutics, Inc. will present positive clinical data from a post-hoc analysis of patients with unilateral knee osteoarthritis (OA) pain from its Phase III trial. The results indicated that patients with unilateral knee OA pain treated with Zilretta (triamcinolone acetonide extended-release injectable suspension) experienced significant and sustained improvements in pain, function, and knee-related quality of life metrics compared with immediate-release triamcinolone acetonide crystalline suspension (TAcs). The data will be presented in a poster session, entitled "Efficacy of triamcinolone acetonide extended-release injectable suspension in patients with unilateral knee osteoarthritis," at the Academy of Managed Care Pharmacy (AMCP) Annual Meeting 2018, taking place April 23 � 26 in Boston.

The post-hoc analysis evaluated the efficacy of Zilretta in a subgroup of patients with unilateral OA pain of the knee. Of the 484 patients enrolled in the Phase III trial, the results of which were recently published, (Journal of Bone and Joint Surgery, Vol 100 (8) pp 666 � 677), 170 (35.1%) had unilateral OA and received either a single IA injection of Zilretta (n=51), TAcs 40mg (n=59) or saline-placebo (n=60). ADP?intensity data were collected daily for up to 24 weeks post?injection. Western Ontario and McMaster Universities OA Index (WOMAC)-A (pain), -B (stiffness), and -C (function) scores, collected at baseline and every four weeks up to 24 weeks post-injection, and Knee Injury and OA Outcome Score Quality of Life (KOOS-QOL) subscale scores, collected at baseline and Weeks 4/8/12/24, were also assessed.

Results indicated that Zilretta provided significant improvement in ADP-intensity at Week 12 compared with placebo (P<0.0001) and tacs p><0.01). zilretta treated patients also appeared to have sustained response over placebo and tacs with respect to improvements in the womac pain stiffness and physical function and koos-qol subscale scores at weeks 4 8 and 12 p><0.05 for all instruments. additionally independent amcp reviewers awarded the abstract a silver ribbon based on assessment across five categories: relevance originality quality bias and clarity. only 20 percent of abstracts submitted for the 2018 meeting were awarded ribbons this year.>

Comment: Zilretta was FDA approved for the management of osteoarthritis pain of the knee in October 2017.