Adequan® (polysulfated glycosaminoglycan) 101: The Company Behind the Product

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*This is the first in a series introducing and educating readers on the Adequan®® (polysulfated glycosaminoglycan) product and the proper use. Stay tuned to HorsesDaily.com as the series continues.* Performance horse exhibitors know the importance of good joint health in their horses. One misstep might mean the difference between the gold and just participating. Horses preparing for the 2014 World Equestrian Games are at the top of their game, and it’s tough to keep them there.

Enter Luitpold Animal Health and their popular product, Adequan®. Adequan® is polysulfated glycosaminoglycan, a joint medication proven to help reverse the effects of degenerative joint disease for equines and canines.

Luitpold Animal Health is a sector of Luitpold Pharmaceuticals based in New York. The company is dedicated to the development and marketing of innovative, quality drugs for healthcare professionals, clinics, and hospitals. There are four different divisions of Luitpold Pharmaceuticals: American Regent, Regency Therapeutics, Animal Health, and Osteohealth.

Those with horses and canines are most familiar with the animal health division because of their flagship Adequan® product. The company now strives for educating the equine owner on joint disease to help you better manage your horse’s physical health.

Like other medicines, Adequan® was more discovered than developed. When Luitpold Pharmaceuticals was looking at a molecule for blood disorders in humans, they discovered that this particular molecule had a dramatic impact on cartilage related to arthritis, explains Senior Manager of Professional Veterinary Services, Victoria Maxwell, DVM, MBA.

“The researchers were looking at polysulfated glycosaminoglycan (PGAG) for potential treatment for blood dyscrasias, and the patient group in the clinical trials remarked that their arthritis felt dramatically better,” says Dr. Maxwell. “So the company began investigating the drug’s interaction with the articular cartilage.”

After initial use in racehorses by a veterinarian in the 1970s, the first variation of Adequan®, the intra-articular (IA) formulation, was approved in 1984 for use in the United States market.

In 1989 Adequan® i.m. (intramuscular) was approved for use in the horse, and then in 1997 Adequan® for canines was approved.

Adequan® and the FDA

“When this drug was reviewed by the Food and Drug Administration (FDA) back in the early 1980s, they had never seen a molecule like this before. It wasn’t an antibiotic, it wasn’t an antihistamine, it wasn’t a steroid,” says Dr. Maxwell. “The academia and research personnel coined a new classification called the Disease Modifying Osteoarthritic Drug, or DOMAD, to which Adequan® is a member. Adequan® remains the only drug that’s ever been approved by the FDA for the treatment of degenerative joint disease in the horse.”

Adequan®, as a veterinary pharmaceutical, is heavily regulated by the FDA, even if it’s just for use for horses and dogs. “Any FDA-approved drugs, including veterinary drugs, are diligently regulated to protect the patient. The FDA regulates and monitors a drug’s manufacturing process, manufacturing facility, marketing, advertising and the actual use of the drug in the marketplace,” says Dr. Maxwell.

Any advertising that goes out the door has to then be submitted to the FDA for review after initial dissemination. If the FDA finds any false claims, a warning letter may be issued, and distribution of the already-disseminated advertisement will need to be ceased.

The most popular route of administration (accounting for 90% of sales) of Adequan® is intramuscular, which is sold in 5mL single dose vials and 50mL multi-dose vials. Maxwell believes this is because of the ease of administration. Because it is an FDA-approved drug, the only way an owner can obtain Adequan® is via prescription through their veterinarian.

Adequan® i.m. is sold in 5mL vials, which is a single dose. The Multi-Dose is a 50mL vial, so there are 10 doses in there for the horse. The only difference between the two is that the Multi-Dose has Benzyl Alcohol—a common preservative in human and animal pharmaceuticals. The preservative is needed if you are going into the vial more than one time with a needle or large volume vials such as phenylbutazone or Banamine vials.

BRIEF SUMMARY:

Adequan® i.m.: For the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. There are no known contraindications to the use of intramuscular Adequan® i.m. brand Polysulfated Glycosaminoglycan in horses. Studies have not been conducted to establish safety in breeding horses. Each 5 mL contains 500 mg Polysulfated Glycosaminoglycan. WARNING: Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Adequan® I.A.: For the intra-articular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal joint in horses. Inflammatory joint reactions and septic arthritis have been reported following administration of Adequan® I.A. Joint sepsis, a rare but potentially life threatening complication, can occur after intra-articular injection. Use only in the carpal joint of horses. Each 1 mL contains 250 mg Polysulfated Glycosaminoglycan. WARNING: Do not use in horses intended for human consumption. Keep this and all medications out of the reach of children. Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

SEE PRODUCT PACKAGE INSERTS FOR FULL PRESCRIBING INFORMATION by going to www.adequan.com, or by calling (800) 458-0163. Adequan® is a registered trademark of Luitpold Pharmaceuticals, Inc. ©LUITPOLD PHARMACEUTICALS, INC., Animal Health Division, Shirley, NY 11967. © 2014

 

 




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