FDA approves first injectable pentosan for osteoarthritis in horses
On Dec. 20, the U.S. Food and Drug Administration approved Zycosan — pentosan polysulfate sodium injection — for the control of clinical signs associated with osteoarthritis in horses. Zycosan is a heparin-like compound and is the first injectable pentosan product to receive FDA approval.
This news was initially reported by AVMA News.
According to a FDA news release, while there is no cure for osteoarthritis, appropriate management can help control the clinical signs of osteoarthritis in horses and improve their quality of life.
FDA said that Zycosan will be an important addition to existing approved drugs to control the clinical signs of osteoarthritis in horses. Unapproved injectable formulations — including compounded formulations — of pentosan have a long history of use in horses, but Zycosan is the first injectable pentosan product to have met FDA standards.
FDA-approved drugs have been demonstrated to be safe and effective for their intended use and have been consistently manufactured to preserve the drugs’ identity, strength, quality, and purity. The FDA strongly encourages veterinarians to use the legally marketed FDA-approved Zycosan when pentosan is indicated for use in an equine patient.
The sponsor of Zycosan conducted a field study in client-owned horses that had lameness in one leg and were diagnosed with osteoarthritis in the lame leg. Horses in the treatment group received Zycosan by intramuscular injection in the neck once every seven days for four weeks for a total of four doses. Horses in the control group were given an equal volume of saline at the same dosage regimen.
Zycosan is sponsored by Anzac Animal Health LLC, based in Maryland Heights, Missouri.
Learn more and read the FDA’s news release on its website.
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