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Intra-Articular, Sustained-Release Triamcinolone Shows Promise in OA Trial
An intra-articular, sustained-release formulation of the steroid triamcinolone acetonide (FX006, Flexion Therapeutics) provides better pain relief than immediate-release triamcinolone acetonide (TCA-IR), according to results from a phase IIb dose-ranging trial in patients with osteoarthritis (OA) of the knee.
Key study results include:
- The optimal dose of FX006 (60 mg) showed a statistically significant and clinically meaningful improvement in the magnitude and duration of pain relief compared with TCA-IR.
- FX006 was well-tolerated, and the systemic exposure produced by FX006 was substantially less than that of TCA-IR.
- All secondary measures, including functional assessment, responder status, patient global impression of change, clinical global impression of change, and rescue medicine consumption, demonstrated significant improvement compared with TCA-IR.
- The onset of pain relief occurred within hours to days, similar to that of TCA-IR.
The phase IIb trial was a double-blind, comparator-controlled study in which 228 patients were randomly assigned to receive 10 mg, 40 mg, or 60 mg of FX006 or 40 mg of TCA-IR via intra-articular knee injection. Efficacy was evaluated using the weekly mean of the average daily pain-intensity score (on the 0-to-10 Numeric Rating Scale) at weeks 1 through 12.
FX006 is a sustained-release, intra-articular formulation of triamcinolone acetonide for the treatment of mild-to-moderate knee OA. It is designed to provide prolonged pain relief while avoiding the untoward systemic effects associated with immediate-release steroids. In preclinical models of OA, FX006 demonstrated both superior efficacy to immediate-release steroids and beneficial effects on structural progression. In a phase II study of pharmacokinetics and pharmacodynamics, FX006 maintained therapeutic concentrations in the knee joint significantly longer than did TCA-IR and showed significantly reduced systemic exposure to the parent steroid compared with the IR formulation.
Source: Flexion Therapeutics; June 26, 2013.