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 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
Fasting Acting. Long Lasting.
Fasting Acting.
Long Lasting.
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:
CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase 3 study
References:
CINGAL 13-01, a randomized, double-blind, placebo-controlled, active comparator Phase 3 study
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.
