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Flexion Theraputics begins phase IIb trial of osteoarthritis drug.

M2 EQUITYBITES-May 2, 2014-Flexion Theraputics begins phase IIb trial of osteoarthritis drug

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Flexion Therapeutics, a US-based pharmaceutical firm, has dosed its first patient in a confirmatory Phase IIb clinical trial of its novel, non-opioid, sustained-release, intra-articular (IA) formulation of triamcinolone acetonide (TCA) 'FX006' as a treatment for relieving pain associated with Osteoarthritis (OA) of the knee, it was reported yesterday.

The trial is designed to further evaluate the safety, tolerability and efficacy of certain doses of FX006. FX006 is designed to offer prolonged pain relief for the treatment of mild to moderate OA of the knee, while avoiding untoward systemic effects related with immediate release steroids.

The company intends to receive topline data from the trial in the first half of 2015 and, if positive, the data would set the stage for Phase III development in 2015.

In the Phase IIb confirmatory trial, about 300 patients will be randomised and treated with a single injection of either 20mg or 40mg of FX006 or placebo and will be evaluated for 20 weeks.The trial's primary outcome measure is the weekly mean of the average daily pain intensity scores as assessed using an 11-point numerical rating scale.

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Publication:M2 EquityBites (EQB)
Date:May 2, 2014
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