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Flexion Therapeutics

From Wikipedia, the free encyclopedia
(Redirected fromFX007)
American biotechnology company
Flexion Therapeutics, Inc.
Company typePublic
NasdaqFLXN
Russell 2000 Component
IndustryPharmaceuticals
Founded2007; 18 years ago (2007)
HeadquartersBurlington, Massachusetts, U.S.
Websiteflexiontherapeutics.com

Flexion Therapeutics, Inc. is an American biopharmaceutical company based inBurlington,Massachusetts that is focused on the discovery, development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning withosteoarthritis (OA), the most common form ofarthritis.[1][2][3]

Flexion was founded around 2007 by two formerEli Lilly and Company executives, Michael Clayman and Neil Bodick, and it went public in 2014.[4]

In November 2016 the FDA accepted Flexion'sNew Drug Application for FX006, an extended-release formulation oftriamcinolone acetonide (acorticosteroid), 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 ofosteoarthritis (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 asfunapide, 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

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  1. ^Gormley, Brian. (28 November 2011)."Flexion Changes Endgame, Advances Osteoarthritis Drugs."Archived 2013-12-24 at theWayback Machine Dow Jones VentureWire.
  2. ^Young, Robin (March 8, 2012)."Could This Be Orthopedics' Future?".Orthopedics This Week. Archived fromthe original on May 14, 2012.
  3. ^"How Flexion Pivoted To Become A Commercial Biotech".www.clinicalleader.com. Retrieved2021-02-09.
  4. ^Weisman, Robert (December 12, 2016)."2 biotechs look to market knee pain treatments - The Boston Globe".Boston Globe.
  5. ^"Triamcinolone acetonide sustained-release". AdisInsight. Retrieved17 July 2017.
  6. ^"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. Retrieved2020-01-24.
  7. ^"Flexion Therapeutics Announces Acquisition of Novel, Non-Opioid Asset for Osteoarthritis of the Knee".www.bloomberg.com. Retrieved2020-01-24.
  8. ^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".
  9. ^"Flexion Therapeutics and Xenon Pharmaceuticals Announce Flexion's Acquisition of an Investigational NaV1.7 Inhibitor for the Treatment of Post-Operative Pain".BioSpace. Retrieved2020-01-24.
  10. ^"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. Retrieved2021-02-09.

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