In a Phase 2a clinical trial, Flexion Therapeutics' (FLXN -1.2%) lead compound FX006 demonstrated sustained therapeutic concentrations of triamcinolone acetonide (TCA) for 12 weeks in knee joints with a single intra-articular injection. The company is developing the non-opioid product for the treatment of osteoarthritis of the knee. Its sustained release qualities may prevent the negative side effects associated with immediate-release steroids.
FX006 showed a six-fold increase in the duration of joint residency compared to immediate-release TCA, the current standard of care injectable therapy. In an earlier pharmacokinetic study, peak plasma concentration of TCA in the hours following injection decreased 40-fold versus immediate-release TCA.
Flexion plans to present more data at an upcoming scientific meeting. It expects to receive top-line data from the Phase 2b confirmatory trial in 1H 2015. A Phase 3 will follow based on the Phase 2b results.