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news.US-based pharmaceutical firm Flexion Therapeutics has completed enrollment of 486 patients in the Phase III clinical trial of its lead compound FX006 about three months earlier than anticipated.
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FX006 is a new, non-opioid, sustained-release, intra-articular (IA) (within the joint) formulation of triamcinolone acetonide (TCA) designed to treat patients with moderate to severe osteoarthritis (OA) pain of the knee.
The company now plans to report topline data from this trial in the first quarter of next year.
The trial will complete the requisite clinical package for the new drug application (NDA) submission of FX006.
The topline clinical data readout from the company’s ongoing Phase IIb trial is expected to be reported this September, about two months ahead of schedule.
FX006 is also intended to provide substantial and persistent pain relief while avoiding systemic side effects.
Flexion Therapeutics president and chief executive officer Michael Clayman said: "We believe the completion of enrollment in this Phase 3 trial positions FX006 ahead of competitive development programs in the US targeting osteoarthritis of the knee, and assuming positive data from both pivotal trials, we will submit an NDA in the second half of 2016 to the FDA for regulatory approval."
The randomized, double-blind Phase III trial is being conducted at over 40 centers worldwide in which patients have been randomized to one of three treatment groups (1:1:1) and treated with a single IA injection of normal saline (placebo), 40mg of FX006 or 40mg of TCA.
The primary objective of the Phase III trials is to evaluate the magnitude and duration of pain relief of FX006 at 12 weeks against placebo.
The trial’s secondary objectives are to evaluate the effect of FX006 on the magnitude and duration of pain relief relative to immediate-release TCA and the effect of FX006 on function, responder status, global impressions of change, stiffness and consumption of analgesic medications relative to both controls.