Triamcinolone acetonide extended-release injectable suspension for knee osteoarthritis treatment

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Triamcinolone acetonide extended-release injectable suspension for knee osteoarthritis treatment

A new drug application (NDA) to the U S Food and Drug AdministrUSFDA) for its lead investigational product, triamcinolone acetonide extended-release injection (also known as FX006), was submitted, which is being assessed to treat patients with osteoarthritis (OA) of the knee. It has accomplished Fast Track designation from the FDA, a designation granted to drugs delibrately to treat serious conditions with the potential to provide significant improvement over existing therapies. 

Based on our pivotal data, triamcinolone acetonide extended-release injection has the potential to be the first intra-articular, extended-release treatment for the many millions of patients who suffer with knee OA. 

The previous reported outcomes from a pivotal Phase 3 clinical trial assists thetriamcinolone acetonide extended-release injection for OA of the knee. Worldwide, 484 patients were enrolled at 37 centers in the randomized, double blind, placebo and active-comparator (immediate-release triamcinolone acetonide (TA) controlled trial. According to the data from the trial, the injection depicted a highly significant (P<0.0001) reduction in average daily pain versus placebo at week 12 (primary endpoint), with durable and clinically meaningful pain relief in patients with moderate to severe OA knee pain. Also, compared to immediate-release TA, the most commonly injected intra-articular corticosteroid achieved statistical significance through 12 weeks on WOMAC A1 (pain), WOMAC B (stiffness) and WOMAC C (function). The frequency of treatment-related side effects was comparable across all treatment arms in the trial.

The commonly observed adverse events for this injection with an incidence greater than 2% were arthralgia, headache, joint swelling and back pain. Due to treatment-related side effect, no drug-related serious adverse events were observed and no patients treated with triamcinolone acetonide were discontinued from the study.

Source:

FDA

Link to the source:

https://www.drugs.com/nda/zilretta_161212.html

Original title of article:

Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain

FDA
SearchTags: 
Therapeutic, Triamcinolone Acetonide Extended-Release, Knee Osteoarthritis, Knee Joint, corticosteroid, Efficacy
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