Flexion Therapeutics, Inc. (FLXN) is a specialty pharmaceutical company. The Company is focused on the development and commercialization of therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), a type of degenerative arthritis and post-operative pain. The Company's portfolio of product candidates addresses the OA pain treatment spectrum, from moderate to severe pain. The Company's lead product candidate, Zilretta (also known as FX006), is a late-stage, injectable, sustained-release, intra-articular (IA) steroid for patients with moderate to severe OA pain. The Company's other product candidates include FX007, a preclinical, small-molecule tropomyosin receptor kinase A (TrkA) receptor antagonist designed to address post-operative pain, and FX005, a sustained-release p38 mitogen-activated protein (MAP), kinase inhibitor for the treatment of end-stage OA patients. The Company has not generated any revenue.
Flexion Therapeutics Receives Positive Guidance from FDA on New Drug Application (NDA) Submission for Zilretta™ for Osteoarthritis of the Knee BURLINGTON, Mass., May 26, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (FLXN) announces that yesterday it received written responses from the U.S. Food & Drug Administration (FDA) to questions the company had submitted in advance of a pre-NDA meeting regarding Flexion’s lead product candidate, Zilretta (also known as FX006). The FDA clearly indicates in its responses that the safety and efficacy data from the registration program for Zilretta are “acceptable to support filing of an NDA submission.” Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes. Read full article here: http://finance.yahoo.com/news/flexion-therapeutics-receives-positive-guidance-110000162.html
