WHAT IS IT?
CINGAL® is the first and only CE mark approved combination product formulated to provide the benefit of a cross-linked hyaluronic acid (HA) and a fast acting steroid. CINGAL is a powerful new single-injection treatment that combines Anika’s proprietary HA formulation with a corticosteroid to effectively treat the symptoms associated with osteoarthritis (OA) providing rapid pain relief that lasts through 6 months.*,1
CINGAL is an off-white, opaque, sterile, single-use suspension of a cross-linked HA gel and a corticosteroid, triamcinolone hexacetonide (TH). CINGAL is biocompatible and non-pyrogenic. CINGAL is designed to ensure that the cross-linked HA and steroid do not physically or chemically interact, delivering maximum stability of each compound in a convenient, single-injection combination treatment.
Micronized particles of the water-insoluble steroid are suspended in the viscoelastic HA gel and reside within CINGAL as a separate solid phase. Both the HA and TH remain unchanged by incorporation into the CINGAL formulation.2
HOW DOES CINGAL WORK?
In the European Economic Area and other parts of the world, CINGAL is indicated as a viscoelastic supplement or a replacement for synovial fluid in human joints. CINGAL is well suited for rapid and long-term relief of the symptoms of human joint dysfunctions such as osteoarthritis. The actions of CINGAL are long-term relief of symptoms by lubrication and mechanical support supplemented by short-term pain relief provided by triamcinolone hexacetonide. Intra-articular corticosteroids are widely used for their potent anti-inflammatory effects. The TH in CINGAL acts as an anti-inflammatory to provide rapid short-term pain relief within days of injection. Unlike other steroids with a shorter duration, TH lasts in the joint for 21 days.3
The hyaluronic acid in CINGAL works to replace some of the natural HA that has been lost due to osteoarthritis. The HA works in parallel to the steroid to provide joint lubrication, mechanical support, and long-term pain relief proven to last through 6 months.1
In Europe and other parts of the world, CINGAL cross-linked hyaluronic acid (HA) with triamcinolone hexacetonide (TH) is a single, intra-articular injection that is injected into the synovial cavity of human joints to relieve the symptoms of osteoarthritis.
In Canada, CINGAL is only approved for use in the knee joint.
WHY IS CINGAL RIGHT FOR YOUR PATIENTS?
CINGAL is an innovative product that extends the proven benefits of Anika’s proprietary high concentration cross-linked hyaluronic acid formulation to a broader range of patients across the spectrum of osteoarthritis management.
THE CINGAL PATIENT
- Athletes who need fast pain relief to return to their sports
- Patients who prefer a single visit
- Patients who desire to remain active
- Patients who demand quick results
- Anyone looking to delay reconstructive surgery4
“The availability of CINGAL is welcome news for millions of Europeans living with osteoarthritis-related knee pain due to a lack of effective, long-lasting, non-surgical treatment options…”
“CINGAL combines two proven, approved therapies for pain and inflammation into a single injection treatment that has been shown to provide immediate pain relief that lasts for 6 months, reduce stiffness, and improve function. For knee pain sufferers, the availability of CINGAL not only translates to postponing an invasive and costly knee replacement surgery, but also to enabling these individuals to resume their normal lifestyle prior to the onset of chronic pain.”
– Prof. Laszlo Hangody Clinical Professor at the Semmelweis Medical School Budapest, former President of the Hungarian Orthopedic Society, and global principal investigator for the CINGAL Phase III program.
* Patient experience may vary
1. CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase III study. Anika Therapeutics, Inc.: study sponsor, Dr. Laszlo Hangody: global principal investigator, SynteractHCR: CRO.
2. R009-041, Technical Report, “Chemical Stability Evaluation of Cross-Linked Hyaluronic Acid and Triamcinolone Hexacetonide in Cingal Product”, December 2009. Appendix II of the device dossier.
3. Stephens M., et. al. Musculoskeletal Injections: A Review of the Evidence. Am Fam Physician. 2008 Oct 15;78(8):971-976.
4. Altman R., Lim S., Steen R., Dasa V. Hyaluronic Acid Injections Are Associated with Delay of Total Knee Replacement Surgery in Patients with Knee Osteoarthritis: Evidence from a Large U.S. Health Claims Database. Osteoarthritis and Cartilage , Volume 23 , A403 – A404; 2015 Dec.