The first patient has been enrolled in a supplemental Phase 3 clinical trial evaluating Anika Therapeutics' (ANIK +0.5%) CINGAL for the treatment of osteoarthritis of the knee. The study will recruit participants at 30 European sites who will receive either CINGAL or triamcinolone hexacetonide over 26 weeks.
The company expects to complete the study next year and anticipates approval in the U.S. in 2019.
CINGAL is a combination viscosupplement that combines the lubricant hyaluronic acid with a steroid (triamcinolone hexacetonide) to treat inflammation. It's the company's third-generation product, following ORTHOVISC and MONOVISC. In clinical studies, patients experienced immediate pain relief lasting six months after a single injection into the knee joint.
Previously: Anika Therapeutics' CINGAL CE Mark'd for arthritis-associated knee pain (March 28, 2016)
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