FDA clears first dual-indication anxiety drug for dogs

The FDA has approved Tessie, a tasipimidine oral solution from Finland-based Orion Corporation, for the treatment of both noise aversion and separation anxiety in dogs. The May 6 approval makes Tessie the first FDA-approved product with both indications on a single label. FDA says the prescription drug is given orally about one hour before a predictable trigger, such as fireworks or a pet parent leaving the home, and it can be dosed up to three times in 24 hours with at least three hours between doses. The agency notes it shouldn’t be given with food because food can delay absorption. (fda.gov)

Why it matters: For veterinary professionals, the approval adds a new short-acting option for dogs with overlapping fear-based behavior problems, a combination behaviorists say is common. In FDA-reviewed field studies, effectiveness for noise aversion was supported in 160 client-owned dogs, while separation anxiety data came from an 8-week study in 224 client-owned dogs. The most commonly reported adverse reactions included vomiting, lethargy, and, in the separation-anxiety study, diarrhea. Christopher Pachel, DVM, DACVB, CABC, told dvm360 that a single drug covering both conditions could help reduce setbacks when dogs encounter “trigger stacking,” such as being left alone during a noise event. (animaldrugsatfda.fda.gov)

What to watch: Watch for rollout details, early clinical uptake, and how practices position Tessie alongside behavior modification rather than as a stand-alone fix. (fda.gov)