Elanco expands Onsior (robenacoxib) line to canine patients

Elanco Animal Health has received FDA approval of Onsior (robenacoxib) Tablets for Dogs and Onsior injection for the treatment of postoperative pain and inflammation associated with soft- tissue surgery in dogs aged 4 months or older and weighing 5.5 pounds or more, according to a company release. Onsior, a nonsteroidal anti-inflammatory drug (NSAID), was previously approved just for cats.

Both the Onsior tablets and injection have been approved for once-daily use for a total of up to three days. The tablets are available in 10-, 20- and 40-mg round, flavored tablets and the injection is available in a single formulation for both dogs and cats.The approved dose, regardless of method of administration, is 2 mg/kg, according to the release.

In a series of studies on the safety and efficacy of Onsior in dogs, the drug was shown to be rapidly absorbed and rapidly cleared from the bloodstream yet persisted at the site of inflammation,1 according to the Elanco release.

In multi-site field studies with both formulations of the drug, client-owned dogs were given Onsior in conjunction with soft-tissue procedures such as ovariohysterectomy, cystotomy, cryptorchidectomy and skin tumor removal. Onsior was given approximately 45 minutes before surgery along with a single dose of butorphanol. Additional once-daily doses of Onsior were given at 24 and 48 hours postoperatively. According to the release, a majority of the treated dogs were evaluated as "treatment successes," in which no additional analgesic medication was required to manage the patient's pain.

The most common adverse reactions noted were gastrointestinal signs such as diarrhea and vomiting, while injection-site discomfort was the leading adverse reaction in dogs administered the injectable formulation.

For full prescribing information, call 1-888-545-5973.

Reference

1. Silber, H., Burgener, C., Letellier, I., et al. 2010. “Population pharmacokinetic analysis of blood and joint synovial fluid concentrations of robenacoxib from healthy dogs and dogs with osteoarthritis.” Pharm. Res. 27.12: 2633-2645.