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New Phase III Study of CINGAL Shows Updated Efficiency

Patient response and safety profile reveal strong results

A PPM Brief

Anika Therapeutics (Bedford, MA) has announced1 results from its CINGAL clinical trial (16-02), an active-comparator Phase III study. CINGAL is the only commercially available combination viscosupplement, a combination of cross-linked hyaluronic acid (HA) and triamcinolone hexacetonide (TH), and is currently indicated for knee pain and discomfort caused by osteoarthritis (OA).

The trial compared the CINGAL combination with TH alone and cross-linked HA in treating patients with OA in the knee. The primary endpoint was a comparison of the pain reduction of CINGAL compared with TH alone at 26-weeks. While CINGAL achieved greater pain reduction numerically at every time point in the study, the difference at 26-weeks was not statistically significant. The patient response to CINGAL in the study was strong, as improvements in pain, function, and quality of life were observed at levels consistent or greater than results from a previous placebo-controlled Phase III study. The safety profile was also similar to previous studies, along with real-world product use.1

“While it has been observed that TH has a longer duration of effect than other corticosteroids, the results in this study were surprising,” said Laszlo Hangody, MD, PhD, principal investigator of several CINGAL trials, in the company’s press release. “Nevertheless, the patient response to CINGAL in this study was strong as patients received statistically and clinically meaningful rapid and long-lasting improvement in symptoms compared with base-line, consistent with the previous study as well as my experience in my practice.”

Follow-up of patients continues in a prospectively designed extension phase to the study, gathering data through 39-weeks.1

Last updated on: June 22, 2018
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