General (3)
Is Polyglycan a generic product?
No. Polyglycan® is a patented 3-component formula which has demonstrated characteristics beyond any of these components used individually. Polyglycan is specifically formulated to have the same viscosity and lubricating properties as natural equine synovial fluid.
Is Polyglycan considered a medical device or a drug?
Polyglycan is a medical device – it achieves therapeutic effect by mimicking the physical properties of equine synovial fluid. The mechanical lubrication and cushioning provided by Polyglycan helps by protecting the joint in a non-chemical/non-metabolic manner.
Is Polyglycan manufactured in an FDA-registered facility?
Yes! The Polyglycan manufacturing facility achieved Current Good Manufacturing Practice (CGMP) status over 10 years ago, and is routinely inspected by FDA.
Are products similar to Polyglycan ever used in humans?
Yes! In fact, all hyaluronic acid products currently used in humans for intra-articular joint treatments are also medical devices.
What is a medical device?
FDA determines a medical device as: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
What are the label claims for the uses of Polyglycan?
Polyglycan is specifically formulated to mimic the physical properties of normal equine synovial fluid. The product’s intended use is in the synovial space (directly in the joint) in horses as a post-surgical lavage, a synovial fluid replacement, or as a viscosupplement.
Equine Studies
Safety when used in horses:
Fred J. Caldwell, DVM, MS, DACVS, Earl M. Gaughan, DVM, DACVS, Melissa Fagerlin, BS BS Dept. of Clinical Sciences, College of Veterinary Medicine, Auburn University, Auburn, Alabama 36830
Safety Evaluation of Polyglycan® in Horses
Safety in horses when used at 1 & 3 times normal dose:
Safety Study on the Effects of Intra-articular Polyglycan at 1X and 3X Doses
CE Kawcak DVM, PhD, Diplomate ACVS Associate Professor, Equine Orthopaedic Research Laboratory, Colorado State University 10-14 08
Efficacy In horses with IA use:
Frisbie DD; Kawcak CE; McIlwraith CW; Werpy NM
Report on the Evaluation of Intra-Articular Polyglycan® for Osteoarthritis using an Equine Model
36th Annual Orthopedic Society Meeting, February 28 - March 6, 2009, Steamboat Springs, Colorado
Compared to other joint treatments:
David D. Frisbie, DVM, PhD, Diplomate ACVS, & ACVSMR Equine Orthopaedic Research Center, Department of Clinical Sciences, College of Veterinary Medicine and Biological Sciences, and Molecular, Cellular & Tissue Engineering, Colorado State University, Fort Collins, Colorado, 80523
Current Evidence on Treatments of Joint Disease
2nd Equine Lameness Research Workshop, Oklahoma City, OK July 24, 2012
Compared to controls in equine joints:
Christopher E. Kawcak, DVM, PhD, Dipl ACVS, C. Wayne McIlwraith, BVSc, PhD, DSc, FRCVS, Dipl ACVS, Gail Holmes Equine Orthopaedic Research Laboratory, Colorado State University, Fort Collins, CO
Comparison of Synovial Fluid in Middle Carpal Joints Undergoing Needle Aspiration, Infusion with Saline, and Infusion with a Combination of N-Acetyl-D-Glucosamine, Hyaluronic Acid, and Sodium Chondroitin Sulfate
Efficacy against single impact load:
Frances M. D., Henson, MA, Vet MB, PhD; Alan M. J. Getgood, MD; David M. Caborn, MD; C. Wayne McIlwraith, DVM, PhD, DSc; Neil Rushton,
Effect of a solution of hyaluronic acid–chondroitin sulfate–N-acetyl glucosamine on the repair response of cartilage to single-impact load damage
American Journal of Veterinary Research, February 2012, Vol. 73, No. 2, Pages 306-312 doi: 10.2460/ajvr.73.2.306
Companion Animal Studies
Safety in dogs, given IA or IM:
MacPhail CM, Brewer M, Hawley JR, Vier J, Lappin MR.
Local & systemic effect of a commercial preparation of CS, HA and NACD-glucosamine when administered IA or IM to healthy dogs
Proceedings of the American College of Veterinary Internal Medicine Annual Forum (abstract), New Orleans, LA June 1, 2012 (poster)
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