Aurora Pharmaceutical is proud to announce the FDA approval of EQUISUL-SDT (Sulfadiazine/Trimethoprim) suspension. EQUISUL-SDT is FDA approved (NADA 141-aaep-20060) for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi subsp. zooepidemicus.

Produced using Aurora’s patented drug product formulation; EQUISUL-SDT demonstrated 20% increased bioavailability over an existing paste product in a pharmacokinetic crossover study. EQUISUL-SDT is approved for oral administration at the dosage of 24 mg combined active ingredients per kilogram body weight (10.9 mg/lb.) twice daily for 10 days. EQUISUL-STD can be administered by volume at 2.7 ml per 45.4 kg (2.7 mL/100 lb.) body weight.

In a controlled field efficacy study of EQUISUL-SDT in horses with lower respiratory tract infections caused by Streptococcus equi subsp. zooepidemicus, 59% (66/112) of the horses receiving EQUISUL- SDT were successfully treated, showing complete resolution of clinical symptoms within seven days after completion of treatment. In contrast, only 15% of the negative control horses demonstrated improvement during the same period. Transtracheal wash samples taken before and after treatment indicated complete bacterial clearance of S. equi subsp. zooepidemicus in 66% of the treated horses. The incidences of adverse events associated with EQUISUL-STD treatment during this study were comparable to those seen in the saline control group and were largely self-limiting. Diarrhea was seen in only 1.1% of the horses treated and resolved without treatment.

In a controlled safety study, horses were administered up to five times the recommended dose of EQUISUL-SDT twice daily for 30 consecutive days. While a higher incidence of loose stool was seen in horses treated with the higher dose of EQUISUL-SDT, in all cases, the incidents were self-limiting and resolved without treatment. EQUISUL-SDT is the only sulfadiazine/trimethoprim product for horses to be tested according to modern FDA requirements. Aurora Pharmaceutical has supply agreements with all major distributors throughout the United States. Please check the website, www.aurorapharmaceutical.com , for the list and contact information