FDA approves first drug for both noise aversion and separation anxiety in dogs

Editor’s Note: Coverage of this approval will continue, with additional expert commentary to follow.

The FDA has approved tasipimidine oral solution (Tessie) for the treatment of noise aversion and separation anxiety in dogs, making it the first FDA-approved product indicated for the 2 conditions in dogs.¹ Although the FDA has previously approved medications for each condition separately, the agency noted this is the first approval covering both indications in a single product.¹

Noise aversion and separation anxiety are fear-related behavioral disorders in dogs that may present with a range of clinical signs. According to the FDA Center for Veterinary Medicine (CVM), dogs with noise aversion may show fear responses to loud stimuli such as fireworks, gunshots, or traffic sounds, whereas dogs with separation anxiety may exhibit distress when left alone.¹ Reported behaviors can include vocalization, trembling, hiding, destruction of household items, and inappropriate elimination.¹ Although behavioral modification may be effective in many cases, the FDA notes that pharmacologic intervention may be appropriate in some patients.¹

Tasipimidine is an α-2 adrenoceptor agonist. According to the FDA CVM, it acts by activating specific receptors in the brain to reduce heightened sympathetic nervous system activity, also known as fight-or-flight responses, associated with noise aversion and anxiety.¹

RELATED VIDEO: Treating noise aversion and separation anxiety together

The product is administered orally approximately 1 hour before a predictable noise event or 1 hour before anticipated owner departure in cases of separation anxiety.¹ It may be given up to 3 times in a 24-hour period, with at least 3 hours between doses.¹ The product should not be administered with food due to delayed absorption, although a small treat may be used to facilitate dosing if needed.¹

The FDA approval was supported by data submitted in the Freedom of Information Summary for NADA 141-627, which included controlled clinical field studies in client-owned dogs.² Effectiveness for noise aversion was demonstrated in a study of 160 dogs, whereas effectiveness for separation anxiety was evaluated in an 8-week study of 224 dogs.² The agency determined the product was safe and effective when used according to labeling.²

The most commonly reported adverse reactions included vomiting and lethargy in dogs treated for noise aversion, as well as vomiting, diarrhea, and lethargy in dogs treated for separation anxiety.² Additional laboratory safety studies in beagles demonstrated dose-dependent, sedation-related effects, including decreased activity, ataxia, and lateral recumbency, along with dose-dependent decreases in heart rate and blood pressure at higher doses.² These effects were generally reversible between dosing intervals.²

Tasipimidine oral solution is a prescription product, as veterinary oversight is necessary for diagnosis and management of noise aversion and separation anxiety in dogs.¹

The product is sponsored by Orion Corporation of Finland.

References

1. FDA approves first drug to treat noise aversion and separation anxiety in dogs. News release. FDA. May 6, 2026. Accessed May 6, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-drug-treat-noise-aversion-and-separation-anxiety-dogs?utm_medium=email&utm_source=govdelivery
2. Freedom of Information (FOI) Summary: NADA 141-627. FDA. May 6, 2026. Accessed May 6, 2026. https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/downloadFoi/18406