Official websites use. Share sensitive information only on official, secure websites. This is a novel treatment for osteoarthritis that is expected to be efficacious and safe for long-term use in cats. Zydax is a known treatment for osteoarthritis and is already approved for use in dogs and horses in Australia. Zydax is used extensively off-label in Australia for treatment of osteoarthritis in cats but no data have been presented from controlled laboratory or field studies using Zydax or any other PPS products in cats.
Parnell has therefore designed four studies to assess efficacy, safety and tolerability in cats prior to pivotal studies. Endpoints were clinical pathology and assessments of the impact of treatment on coagulation parameters; for example, activated partial thromboplastin time aPTT , fibrinogen, prothrombin time PT and buccal mucosal bleeding time scores as well as clinical observations and adverse events. Efficacy endpoints include client-specific outcome measures CSOMs and activity monitoring data.
The CSOMs are tailored for each cat and owner to identify tasks that are impeded due to osteoarthritis, and assessment is made of whether they improve during the course of the study. Activity monitoring will identify changes in mobility related to relief of osteoarthritic pain. The safety studies identified no clinically or toxicologically significant effects of Zydax on clinical chemistry or hematology. However, a transient and proportional prolongation of aPTT and PT was noted after dosing; these parameters returned to normal by 18 h in all but the top dose group where two cats remained over reference interval for 48 h.
Fibrinogen was within normal limits, except for one cat, which returned to normal by 24 h. A dose-proportional lymphocytosis was also noted and returned to normal by 24 h. A dose-proportional effect on pain was seen during injection, but resolved immediately.
Mild erythema and bruising were noted in several cats, but neither adverse event was prolonged and both resolved without intervention.
