In this study, the safety and efficacy of an spot on formulation composed of Fluralaner (40mg/kg)and Moxidectin (2mg/kg) against internal and external parasites was evaluated in Korean cats. The product was developed as a topical use in cats to prevent or control internal and external parasites including ticks, fleas, gastrointestinal parasites, ear mite and heartworm. As a result of the study, targeted for total 30 cats from 8 Korean animal hospitals, this combination of Fluralaner and Moxidectin was found to be very safe in cats, and its effectiveness against external parasites (ticks, fleas, and ear mites) was fully verified. In addition, As the animals exposed in the infective circumstances of heartworm and gastrointestinal parasites were remained negative during the study period of 12 weeks after treatment of test drug, it was determined that this product had a potential preventive effect against the heartworms and gastrointestinal parasites.
GN01 is a new antiviral medicine acting against Korean Sacbrood virus (KSBV) of honeybees. It contains 5 mg/mL of active ingredient, double stranded RNAs(dsRNA), that homologous to KSBV ribonucleic acid coding coat protein (VP1) of virus and inducing RNA interference (RNAi). RNA medicine is generally recognized as safe for rapid breakage by intrinsic ribonuclease and limited absorption from gastrointestinal tract. However, there were no data of repeat-dose toxicity in laboratory animals for dsRNA targeting SBV. This study was performed to investigate toxicity of GN01 in SD rats after weekly oral dosing for 28 days and to determine its no-observed-adverse-effect-level (NOAEL). Male and female SD rats were orally administered with GN01 at 0, 25, 50 and 100 mg/kg bw/day of dsRNA once per week for 28 days (total 5 administrations). The highest dose 100 mg/kg bw/day was determined based on the maximum volume injectable (20 mL/kg bw) via gavage. During treatment period, clinical signs, functional and sensory responses, body weights, food and water consumption, ophthalmological findings and urinalysis were investigated. After treatment period, hematological and clinical biochemistry tests and examination of necropsy findings, organ weights and histopathological lesions were performed. There were no significant differences between all test groups and vehicle control group in all measured parameters. Therefore, the NOAEL of GN01 was determined 100 mg/kg bw/day, the highest dose administered. In conclusion, repeated oral administration of GN01, a dsRNA medicinal product, is safe even at the maximum available dose in rats.