Anika Therapeutics Cingal Tops Steroid For Osteoarthritis Pain Relief

Vandana Singh
1 min read
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In this article:

  • Anika Therapeutics Inc (NASDAQ: ANIK) 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.

  • Also see: New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio

  • 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.

  • Price Action: ANIK shares are up 1.86% at $28.95 on the last check Tuesday.

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