BioCentury
ARTICLE | Clinical News

Flexion provides FX006 update

September 4, 2014 12:49 AM UTC

Flexion Therapeutics Inc. (NASDAQ:FLXN) 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 one of two efficacy trials to support an NDA for a single-dose administration of the sustained-release intra-articular formulation of triamcinolone acetonide.

Flexion previously said it would also need a repeat-dose Phase III trial of FX006 to support an NDA. The company had planned to start it later this year, but said it now will begin the repeat-dose trial following FDA approval of FX006. ...