Flexion Therapeutics

Last updated
Flexion Therapeutics, Inc.
Company type Public
Nasdaq:  FLXN
Russell 2000 Component
Industry Pharmaceuticals
Founded2007;17 years ago (2007)
Headquarters Burlington, Massachusetts, U.S.
Website flexiontherapeutics.com

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]

Related Research Articles

<span class="mw-page-title-main">Osteoarthritis</span> Form of arthritis caused by degeneration of joints

Osteoarthritis (OA) is a type of degenerative joint disease that results from breakdown of joint cartilage and underlying bone. It is believed to be the fourth leading cause of disability in the world, affecting 1 in 7 adults in the United States alone. The most common symptoms are joint pain and stiffness. Usually the symptoms progress slowly over years. Other symptoms may include joint swelling, decreased range of motion, and, when the back is affected, weakness or numbness of the arms and legs. The most commonly involved joints are the two near the ends of the fingers and the joint at the base of the thumbs, the knee and hip joints, and the joints of the neck and lower back. The symptoms can interfere with work and normal daily activities. Unlike some other types of arthritis, only the joints, not internal organs, are affected.

<span class="mw-page-title-main">Joint injection</span> Method of delivering drugs into a joint

In medicine, a joint injection is a procedure used in the treatment of inflammatory joint conditions, such as rheumatoid arthritis, psoriatic arthritis, gout, tendinitis, bursitis, Carpal Tunnel Syndrome, and occasionally osteoarthritis. A hypodermic needle is injected into the affected joint where it delivers a dose of any one of many anti-inflammatory agents, the most common of which are corticosteroids. Hyaluronic acid, because of its high viscosity, is sometimes used to replace bursa fluids. The technique may be used to also withdraw excess fluid from the joint.

<span class="mw-page-title-main">Triamcinolone acetonide</span> Medicinal chemical compound, steroid

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References

  1. Gormley, Brian. (28 November 2011). "Flexion Changes Endgame, Advances Osteoarthritis Drugs." Dow Jones VentureWire.
  2. Young, Robin (March 8, 2012). "Could This Be Orthopedics' Future?". Orthopedics This Week. Archived from the original on May 14, 2012.
  3. "How Flexion Pivoted To Become A Commercial Biotech". www.clinicalleader.com. Retrieved 2021-02-09.
  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. Retrieved 17 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. Retrieved 2020-01-24.
  7. "Flexion Therapeutics Announces Acquisition of Novel, Non-Opioid Asset for Osteoarthritis of the Knee". www.bloomberg.com. Retrieved 2020-01-24.
  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. Retrieved 2020-01-24.
  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. Retrieved 2021-02-09.