Anika Therapeutics announced results from the Phase III clinical trial of CINGAL® to support U.S. registration. A previous placebo-controlled Phase III trial demonstrated safety and efficacy through 26 weeks, while the current trial compared CINGAL, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA to treat knee osteoarthritis (OA). 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 did not reach statistical significance.
Researchers observed significant improvements in pain, function and quality of life at levels consistent with or greater than results of the placebo-controlled study, as well as a strong safety profile. Patient follow-up in a prospectively designed extension phase will gather data through 39 weeks.
CINGAL is Anika’s third-generation viscosupplement, following ORTHOVISC and MONOVISC, to treat knee OA pain. Anika will continue to work with regulators to gain U.S. approval of CIGNAL.
Anika Therapeutics announced results from the Phase III clinical trial of CINGAL® to support U.S. registration. A previous placebo-controlled Phase III trial demonstrated safety and efficacy through 26 weeks, while the current trial compared CINGAL, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and...
Anika Therapeutics announced results from the Phase III clinical trial of CINGAL® to support U.S. registration. A previous placebo-controlled Phase III trial demonstrated safety and efficacy through 26 weeks, while the current trial compared CINGAL, a combination of cross-linked HA and triamcinolone hexacetonide (TH), with TH alone and cross-linked HA to treat knee osteoarthritis (OA). 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 did not reach statistical significance.
Researchers observed significant improvements in pain, function and quality of life at levels consistent with or greater than results of the placebo-controlled study, as well as a strong safety profile. Patient follow-up in a prospectively designed extension phase will gather data through 39 weeks.
CINGAL is Anika’s third-generation viscosupplement, following ORTHOVISC and MONOVISC, to treat knee OA pain. Anika will continue to work with regulators to gain U.S. approval of CIGNAL.
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