Zilretta shows clinical improvement for knee osteoarthritis pain: 5 key notes

Written by Laura Dyrda | November 11, 2016 | Print  |

Flexion Therapeutics' lead investigational product candidate Zilretta, also known as FX006, demonstrated clinically and statistically significant improvement in a Phase III trial for patients with knee osteoarthritis.

Here are five key notes:

 

1. The company is investigating Zilretta as an intra-articular extended-release, non-opioid treatment for patients with moderate to severe knee osteoarthritis pain. The proprietary technology combines triamcinolone acetonide with a polymer designed to provide persistent concentrations of the drug locally.

 

2. The randomized, double-blind, placebo-controlled, active comparator trial included 484 patients at 37 centers worldwide. Zilretta achieved the primary endpoint of the trial, which was to significantly reduce pain as measured by the average daily pain score at 12 weeks after treatment.

 

3. Zilretta achieved statistically significant improvements in WOMAC A, B and C at four weeks, eight weeks and 12 weeks after treatment when compared with a placebo and immediate-release triamcinolone acetonide.

 

4. Zilretta demonstrated clinically meaningful effects in pain, stiffness and function after exceeding the minimum clinically important improvement thresholds 12 weeks after treatment; immediate-release triamcinolone acetonide did not.

 

5. There weren't any serious drug-related adverse events, and the adverse events that did occur were balanced across arms and generally mild.

 

"These results demonstrate that Zilretta significantly improves pain, stiffness and function in patients with OA of the knee compared to placebo and immediate release steroid," said Andrew Spitzer, MD, director of the joint replacement program at Cedars-Sinai Orthopaedic Center in Los Angeles.

 

The company is on track to submit an NDA to the FDA in December.

 

More articles on orthopedic devices:
Globus Medical reports Q3 revenue of $135.7M—5 highlights
University of Iowa Hospitals and Clinics joins InVivo Therapeutics' INSPIRE study
SeaSpine earns FDA clearance for Mariner Posterior Fixation System

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