Powerful new treatment for the pain of osteoarthritis.

Fast acting. Long lasting

Powerful new treatment for the pain of osteoarthritis.

Fast acting. Long lasting

What is CINGAL?

What is CINGAL?

CINGAL® is the first and only approved combination viscosupplement formulated to provide the benefit of a cross-linked hyaluronic acid and a fast acting steroid.

CINGAL® is a novel combination HA plus steroid single-injection treatment for the pain associated with osteoarthritis. CINGAL® combines the high molecular weight cross-linked hyaluronic acid (HA) formulation of MONOVISC® with a corticosteroid for additional short-term pain relief.
CINGAL® is the first and only approved combination viscosupplement formulated to provide the benefit of a cross-linked hyaluronic acid and a fast acting steroid.
CINGAL® is a novel combination HA plus steroid single-injection treatment for the pain associated with osteoarthritis. CINGAL® combines the high molecular weight cross-linked hyaluronic acid (HA) formulation of MONOVISC® with a corticosteroid for additional short-term pain relief.

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 unique function of CINGAL

The unique function of CINGAL

CINGAL combines Anika’s proprietary cross-linked hyaluronic acid formulation, MONOVISC with proven effects through 6 months, with a well-established FDA approved steroid, triamcinolone hexacetonide.
Only CINGAL works by combining the best of fast acting steroids with a long-lasting viscosupplement to deliver rapid pain relief proven to last through 6 months
CINGAL combines Anika’s proprietary cross-linked hyaluronic acid formulation, MONOVISC with proven effects through 6 months, with a well-established FDA approved steroid, triamcinolone hexacetonide.
Only CINGAL works by combining the best of fast acting steroids with a long-lasting viscosupplement to deliver rapid pain relief proven to last through 6 months

Fasting Acting. Long Lasting.

The unique combination of high concentration cross-linked hyaluronic acid formulation with a well-established FDA approved steroid provides rapid pain relief that lasts through 6 months.

Fasting Acting.
Long Lasting.

The unique combination of high concentration cross-linked hyaluronic acid formulation with a well-established FDA approved steroid provides rapid pain relief that lasts through 6 months.

CINGAL shows highly statistically significant improvement compared to saline at all secondary endpoint at 26 weeks

CINGAL shows highly statistically significant improvement compared to saline at all secondary endpoint at 26 weeks

References:

Anika data on file

CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase 3 study

CINGAL demonstrated a very strong safety profile in its clinical study. There were no serious adverse events related to the study device There were only six adverse events related to the study device including joint pain, rash and swelling, which are common and minor side effects seen with viscosupplements and were all resolved naturally.

References:

Anika data on file

CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase 3 study

CINGAL demonstrated a very strong safety profile in its clinical study. There were no serious adverse events related to the study device There were only six adverse events related to the study device including joint pain, rash and swelling, which are common and minor side effects seen with viscosupplements and were all resolved naturally.

IS RETREATMENT CLINICALLY SAFE?

A retreatment was conducted in CINGAL 13-02 after the original Cingal study, CINGAL 13-01.

The safety of a repeat injection of CINGAL was confirmed in the CINGAL 13-02 study.

In the CINGAL 13-02 study, 94 patients who had received CINGAL initially (from CINGAL 13-01), received an open-label injection of CINGAL 6 months after first injection. The primary end point of this study was adverse events (AEs). The key findings of the study were:

• A low number of subjects (4.3%) experienced an adverse event (AE) related to the study injection. The observed AEs were mainly associated with viscosupplements (arthralgia, injection site pain, swelling, and erythema), and over 95% were considered ‘mild’ or ‘moderate’ in severity. All AEs were transitory, resolving without treatment.

• The AE rate associated with CINGAL was found to be consistent across both first-time and repeat injection studies. There were no statistically significant differences between the AE profile of participants in the CINGAL 13-01 study (single injection) and those in the CINGAL 13-02 study (repeat injection).

In summary, the results of this secondary study combined with the initial Phase 3 data show that CINGAL maintains a consistently strong safety profile in both an initial injection as well as a repeat injection.

IS RETREATMENT CLINICALLY SAFE?

A retreatment was conducted in CINGAL 13-02 after the original Cingal study, CINGAL 13-01.

The safety of a repeat injection of CINGAL was confirmed in the CINGAL 13-02 study.

In the CINGAL 13-02 study, 94 patients who had received CINGAL initially (from CINGAL 13-01), received an open-label injection of CINGAL 6 months after first injection. The primary end point of this study was adverse events (AEs). The key findings of the study were:

• A low number of subjects (4.3%) experienced an adverse event (AE) related to the study injection. The observed AEs were mainly associated with viscosupplements (arthralgia, injection site pain, swelling, and erythema), and over 95% were considered ‘mild’ or ‘moderate’ in severity. All AEs were transitory, resolving without treatment.

• The AE rate associated with CINGAL was found to be consistent across both first-time and repeat injection studies. There were no statistically significant differences between the AE profile of participants in the CINGAL 13-01 study (single injection) and those in the CINGAL 13-02 study (repeat injection).

In summary, the results of this secondary study combined with the initial Phase 3 data show that CINGAL maintains a consistently strong safety profile in both an initial injection as well as a repeat injection.

What to know more about the product?

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