Flexion Therapeutics
| Company type | Public |
|---|---|
| Nasdaq: FLXN Russell 2000 Component | |
| Industry | Pharmaceuticals |
| Founded | 2007 |
| Headquarters | Burlington, Massachusetts, U.S. |
| Website | flexiontherapeutics |
Flexion Therapeutics, Inc. is an American biopharmaceutical company based in Burlington, Massachusetts that is focused on the discovery, development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA), the most common form of arthritis.[1][2][3]
Flexion was founded around 2007 by two former Eli Lilly and Company executives, Michael Clayman and Neil Bodick, and it went public in 2014.[4]
In November 2016 the FDA accepted Flexion's New Drug Application for FX006, an extended-release formulation of triamcinolone acetonide (a corticosteroid), branded "Zilretta".[5] In October 2017 Zilretta was approved by the FDA as the first and only extended-release intra-articular therapy for patients confronting osteoarthritis-related knee pain.[6]
In December 2017, Flexion acquired an investigational gene therapy product candidate for the treatment of osteoarthritis (OA), known as FX201.[7] In late 2019, the company initiated a Phase 1 clinical trial evaluating safety and tolerability of FX201 in 15-24 patients. Flexion believes FX201 holds the potential to provide extended relief from OA knee pain for at least six to 12 months and modify the disease.[8]
In September 2019, Flexion announced the development of FX301, a locally administered NaV1.7 inhibitor product candidate, known as funapide, formulated for extended release in a thermosensitive hydrogel. The initial development of FX301 is intended to support administration as a peripheral nerve block for control of post-operative pain. Flexion believes FX301 has the potential to provide effective pain relief while preserving motor function and anticipates initiating clinical trials in 2021.[9][10]
References
[edit]- ^ Gormley, Brian. (28 November 2011). "Flexion Changes Endgame, Advances Osteoarthritis Drugs." Dow Jones VentureWire.
- ^ Young, Robin (March 8, 2012). "Could This Be Orthopedics' Future?". Orthopedics This Week. Archived from the original on May 14, 2012.
- ^ "How Flexion Pivoted To Become A Commercial Biotech". www.clinicalleader.com. Retrieved 2021-02-09.
- ^ Weisman, Robert (December 12, 2016). "2 biotechs look to market knee pain treatments - The Boston Globe". Boston Globe.
- ^ "Triamcinolone acetonide sustained-release". AdisInsight. Retrieved 17 July 2017.
- ^ "Flexion Therapeutics Announces FDA Approval of Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis (OA) Knee Pain". GlobeNewswire News Room (Press release). 2017-10-06. Retrieved 2020-01-24.
- ^ "Flexion Therapeutics Announces Acquisition of Novel, Non-Opioid Asset for Osteoarthritis of the Knee". www.bloomberg.com. Retrieved 2020-01-24.
- ^ Flexion Therapeutics, Inc. (2020-09-16). "An Open-Label, Single Ascending Dose Study to Assess the Safety and Tolerability of FX201 in Patients With Osteoarthritis of the Knee".
- ^ "Flexion Therapeutics and Xenon Pharmaceuticals Announce Flexion's Acquisition of an Investigational NaV1.7 Inhibitor for the Treatment of Post-Operative Pain". BioSpace. Retrieved 2020-01-24.
- ^ "Flexion Therapeutics Announces Positive Preclinical Data Supporting Development of FX301, a Locally Administered Nav1.7 Inhibitor Product Candidate for Post-Operative Pain". GlobeNewswire News Room (Press release). 2020-04-27. Retrieved 2021-02-09.
