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Sustained-Release Steroid Shows Promise in Knee OA
Sustained-release triamcinolone more effective than suspension formulation (October 30)
Positive data from a phase IIb dose-ranging trial of FX006 (Flexion Therapeutics) — a sustained-release, intra-articular formulation of triamcinolone acetonide (TCA) — have been presented at the 2013 American College of Rheumatology (ACR) Annual Scientific Meeting in San Diego, California.
In the 12-week study, patients with osteoarthritis (OA) of the knee receiving a single injection of FX006 experienced enhanced pain relief compared with patients that received the currently approved injectable suspension of TCA.
The double-blind, comparator-controlled trial evaluated 229 patients with mild-to-moderate knee OA who were treated with either FX006 (10, 40, or 60 mg) or TCA suspension (40 mg) via intra-articular knee injection. The study’s primary outcome measure was the weekly mean of the average daily pain intensity score (on the Numeric Rating Scale) at weeks 1 through 12. Secondary endpoints included the time to onset of analgesia, responder status, pain, stiffness, and function.
FX006 40 mg was significantly better than TCA suspension at improving pain relief, based on the primary outcome measure, beginning at week 5 and continuing to week 10 (P < 0.05 at each time point). The 40-mg dose of FX006 also demonstrated significant improvement compared with TCA suspension in the average change from baseline in the primary outcome measure across weeks 1 to 12 (P = 0.0382).
In addition, at week 8 all key secondary endpoints demonstrated significant improvement with the 40-mg dose of FX006 compared with TCA suspension (P < 0.05).
FX006 40 mg was well-tolerated, with a safety profile that was comparable with that of the same dose of the TCA comparator.
Source: Flexion Therapeutics; October 30, 2013.