Flexion Starts Phase III Enrollment On Zilretta For Hip OA
Zacks Investment Research | Jan 02, 2019 10:26PM ET
Flexion Therapeutics, Inc. (NASDAQ:FLXN) announced that it enrolled the first patient in a phase III study on its pain drug, Zilretta (triamcinolone acetonide extended-release injectable suspension), for the treatment of patients with hip osteoarthritis (OA) on Dec 26, 2018. This late-stage study will evaluate the safety and efficacy of Zilretta, already approved by the FDA for pain management in patients with knee OA since October 2017.
Zilretta was approved as the first and the only extended-release intra-articular (IA) therapy, providing relief from pain for over a period of 12-weeks.
The initiation of this phase III program was based on positive data from the open-label phase II SHIP study. Data from the latter showed that Zilretta was safe and well tolerated. The final result read-out from this label expansion analysis is expected in 2020.
The phase III study will evaluate Zilretta on 440 patients with hip OA. Patients were randomly administered with either a single IA injection of Zilretta or placebo. The primary endpoint of the study is to assess the pain relief at week 12 compared with placebo measured by the WOMAC scale.
Flexion also plans to begin additional phase II studies on Zilretta for treating shoulder OA and shoulder adhesive capsulitis (frozen shoulder) later this year.
Shares of Flexion have plummeted 51.2% in the past year, significantly wider than the Zacks Investment Research
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