FDA Approves The First Injectable Pentosan For Equine Osteoarthritis
The FDA announced on December 20, 2022, that Zycosan (pentosan polysulfate sodium injection) had been approved to control clinical signs associated with osteoarthritis in horses.
Zycosan, which contains pentosan polysulfate sodium, has been approved for injection in horses by the FDA. Zycosan is a heparin-like compound approved by the FDA as the first injectable pentosan product.
The gradual breakdown of joint cartilage characterizes osteoarthritis. It can cause various clinical symptoms, such as lameness, stiffness, and joint swelling. While there is no cure for osteoarthritis in horses, proper management can help control the clinical signs of the disease and improve their quality of life.
According to the FDA, Zycosan will be an essential addition to approved drugs for controlling the clinical signs of osteoarthritis in horses. Unapproved injectable formulations of pentosan, including compounded formulations, have been used in horses for a long time. Zycosan, on the other hand, is the first injectable pentosan product to meet FDA safety, efficacy, and consistency standards. When pentosan is indicated for use in an equine patient, the agency strongly advises veterinarians to use legally marketed, FDA-approved Zycosan.
Anzac Animal Health LLC, the Zycosan sponsor, conducted a field study on client-owned horses with lameness in one leg and osteoarthritis in the lame leg. Zycosan was administered intramuscularly in the neck of horses in the treatment group once every seven days for four weeks, total four doses. The control horses received an equal volume of saline at the same dosage regimen. On day 28, more horses in the Zycosan-treated group improved their lameness grades than those in the control group.
According to the FDA, because pentosan polysulfate sodium is a weak anticoagulant, people who take an anticoagulant should exercise caution when handling or administering Zycosan.
Zycosan should be administered intramuscularly once weekly for four weeks at a dose of 3 mg/kg (1.4 mg/lb). The product comes in a single-use 7.5-mL vial.