Synedgen’s Synoplex® Receives FDA Indexing for use in the treatment of chronic wounds in pachyderms

June 26, 2012 — Claremont CA—Elephants and Rhinoceroses frequently encounter chronic non- healing infected abscesses and cutaneous wounds that become resistant to traditional antibiotics and treatments. Over time, these wounds can have serious long-term consequences such as systemic infections and impaired mobility. Recognizing the difficulty in treating these types of wounds, the FDA’s Center for Veterinary Medicine has recently allowed Synedgen to market Synoplex®, Synedgen’s veterinary wound rinse product, as an FDA Indexed Product to treat infected, chronic and non-infected wounds in elephants and rhinoceroses. Synoplex is intended for the treatment of chronic foot disease (cracked nails, abscesses, lesions, ulcers, fissures) and chronic non-healing dermal or subdermal wounds such as abscesses and pressure sores caused by chronic inflammation or bacterial species. Synoplex® is also intended for use as a regular treatment for non-infected wounds at a lower dose.

Data have shown that Synoplex breaks up established biofilms, flushes the bacteria from the wounds, and inhibits the formation of biofilms, providing a safe, prophylactic and therapeutic treatment for both chronic and acute infections associated with dermal wounds and foot disease in elephants and rhinoceroses. In addition, Synoplex has been shown to encourage wound healing, unlike other topical disinfectants that are damaging to tissue.

“Synoplex provides a breakthrough technology for treating both chronic and acute topical infections by eliminating the need for antibiotics,” stated Synedgen President Shenda Baker. “This product is perfectly suited for large topical wound application in elephants and rhinoceroses, as it is safe for the veterinarian and animal and heals the wound while preventing or treating infection.”

Currently, wounds in elephants and rhinoceroses are treated with systemic or topical antibiotics as well as topical disinfectants, such as chlorhexidine or Betadine. These disinfectants are great at reducing bacteria, but they are very harsh on the wound and can inhibit healing. The cost of systemic antibiotics in these large animal species can be cost prohibitive and disrupt their gut flora. Synoplex can be used for Gram-positive or Gram negative bacterial infections, as well as in non-infected wounds.

An expert panel of renowned veterinarians unanimously concluded that Synoplex is effective and safe for use in the family Elephantidae and the family Rhinocerotidae in December 2011. The panel notes the importance of new treatments for infection in its recommendation, “Often these chronically infected wounds have been treated repeatedly with various antimicrobials resulting in development of multiple drug resistant strains of bacteria. The advantage of treating these infections without use of an antimicrobial is a major benefit to the patients and to the caretakers.” Synoplex Panel Member Head Veterinarian Dr. Ralph Zimmerman of the Albuquerque BioPark remarked, “Synoplex provides a safe, prophylactic and therapeutic treatment for controlling and preventing bacterial biofilms and treating both chronic and acute infections associated with dermal wounds and foot disease. Use of Synoplex has demonstrated effectiveness without any adverse effects. Likewise, there is minimal concern for the veterinarian or other caretakers applying Synoplex to their patients as there have been no known allergic reactions or adverse events reported.”

The Office of Minor Use and Minor Species Animal Drug Development (OMUMS) maintains an index of legally marketed unapproved new animal drugs and their designated intended uses for minor species. Synoplex® is legally marketed as an FDA Indexed Product under MIF 900-012.