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Flexion Therapeutics, Inc.
Drug Names(s): FX-006, FX006
Description: FX006 is a sustained-release formulation of triamcinolone acetonide for the treatment of mild to moderate osteoarthritis (OA) of the knee. It is designed to provide prolonged pain relief while avoiding untoward systemic effects associated with steroids as front-line therapy. In preclinical models of OA, FX006 demonstrates superior efficacy to immediate release steroids and demonstrates beneficial effect on structural progression.
Flexion and Patheon
In August 2015, Flexion Therapeutics announced it has entered into a strategic manufacturing and supply agreement with Patheon for the manufacture of FX006. Patheon and Flexion will establish a dedicated manufacturing suite at Patheon's specialty sterile manufacturing facility in Swindon, England, to allow Flexion greater control of unit production and provide added scale to meet long-term product demand.
Under the agreements with Patheon, Patheon will be responsible for the construction of the dedicated manufacturing suites, installation and validation of the manufacturing equipment and the potential commercial manufacture of FX006. Flexion will oversee the purchase and design of the dedicated manufacturing equipment to be installed in the facility and will have personnel on-site to ensure the optimization of Flexion's proprietary manufacturing process.
Partners: Patheon, Inc.
Pink Sheet FDA Performance Tracker: User Fee Goal Dates
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