ARTICLE | Clinical News

FX006 regulatory update

September 8, 2014 7:00 AM UTC

Flexion said it now expects to complete Phase III development of FX006 to treat moderate to severe osteoarthritis (OA) knee pain by the end of 2015 -- a year earlier than the company had previously expected. According to Flexion, FDA said it would consider an ongoing Phase IIb trial of FX006 to be 1 of 2 efficacy trials to support an NDA for a single-dose formulation of the product.

Flexion now plans to start a Phase III trial of FX006 late this year instead of the middle of next year. The double-blind, placebo-controlled, international Phase III trial will compare 40 mg FX006 vs. 40 mg immediate-release triamcinolone acetonide in about 462 patients with OA of the knee for 12 weeks. Data from the ongoing Phase IIb trial are expected next half, with data from the Phase III trial expected by the end of 2015 and an NDA submission to FDA expected in 1H16. ...