Anika Therapeutics Cingal Tops Steroid For Osteoarthritis Pain Relief
- Anika Therapeutics Inc announced that Cingal met its primary endpoint in a Phase 3 Study (Cingal 19-01), demonstrating superiority over triamcinolone hexacetonide (TH) steroid alone at 26 weeks post-treatment.
- Cingal is a combination product of cross-linked hyaluronic acid (HA) proven to provide long-lasting pain relief through 6 months plus TH steroid to provide fast, short-term pain relief to treat the pain of knee osteoarthritis (OA).
- Cingal is currently sold in more than 35 countries outside the U.S.
- Anika will engage with the FDA on the next steps for U.S. regulatory approval in the coming months.
- In parallel, Anika is exploring the potential to advance Cingal through commercial partnerships in the U.S. and select Asian markets.
- In addition, Cingal demonstrated strong performance for pain reduction with 66% improvement in Pain Index (-44.3mm from baseline), and 90% of subjects were deemed to be OMERACT-OARSI Responders, a recognized method of evaluating responder rates based on improvement in pain and function.
- Cingal was well-tolerated in the study, with only transient and non-serious adverse events (e.g., arthralgia, injection site pain, swelling, stiffness) related to the study injections.
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