The U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA-CVM) announced today that it has approved the drug Pexion to treat noise aversion in dogs. Pexion is known generically as imepitoin and is already approved to treat epilepsy in dogs.

Dogs with noise aversion are afraid of loud noises such as fireworks, traffic noises and gun shots, and may exhibit behaviors such as hiding, vocalizing, panting, trembling, vomiting, urinating or defecating with the occurrence of such noises. Dogs with severe noise aversion may even damage furniture, doors, dog beds, or other items in their surroundings.

The effectiveness of Pexion was evaluated in a study of client-owned dogs that had previously demonstrated noise aversion behaviors in response to fireworks. The dogs received either Pexion or a placebo twice daily beginning two days prior to New Year’s Eve, when fireworks events were scheduled to be held, with treatment continuing through New Year’s Eve, according to the FDA. “The owners of 66 percent of dogs receiving Pexion scored the overall treatment effect as excellent or good, compared with 25 percent of dogs receiving the placebo.”

Possible side effects of Pexion may include difficulty standing and walking, increased appetite, lethargy, and vomiting. Certain drugs used to reduce anxiety, such as Pexion, may lead to lack of self-control of fear-based behaviors and may therefore result in a change in aggression level, according to the FDA. “The owners of three of the 90 dogs that received Pexion in the effectiveness trial also reported that their dogs became aggressive, including growling towards a young child and lack of restraint or self-control towards other dogs.”

Pexion is available only by prescription and a licensed veterinarian will need to determine whether it is an appropriate treatment. Pexion is manufactured by Boehringer Ingelheim Vetmedica Inc., of St. Joseph, Missouri.

Click here to read the full FDA announcement and for more detail about the data and studies the FDA reviewed in its evaluation and approval of Pexion.