December 4, 2018
The U.S. Food and Drug Administration announced today that its Center for Veterinary Medicine has approved Pexion (imepitoin tablets) to treat noise aversion in dogs. Dogs with noise aversion are sensitive to loud noises such as fireworks, street/traffic noises, and gun shots. Dogs may show their distress through hiding; vocalizing (whining, barking, howling); panting, shaking or trembling; or may vomit, urinate or defecate. Some dogs may 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 for two days prior to New Year’s Eve, when fireworks events were scheduled to be held. Treatment continued through New Year’s Eve. The owners evaluated their dogs’ responses to the fireworks at four pre-set intervals and scored the level of 16 different behaviors. The overall score for the dogs receiving Pexion were lower (better) than those receiving the placebo.
The owners also evaluated the overall effect of treatment based on previous New Year’s Eve fireworks experiences with the dogs. 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.
Pexion is administered to the dog twice daily starting two days before an expected noise event and continued through the event. It is available in 100 mg or 400 mg scored tablets and is dosed according to the weight of the dog.
The most common adverse reactions seen in the study were ataxia (difficulty standing and walking), increased appetite, lethargy, and vomiting.
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. 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. The label information accompanying Pexion notes the recommendation that owners should carefully observe their dogs during treatment.
Pexion will be available by prescription only, because a licensed veterinarian is needed to determine whether Pexion is an appropriate treatment.
As with any drug, veterinarians and owners of dogs that experience adverse events should report them to the manufacturer, who is required to report them to the FDA. Veterinarians and pet owners can also file a report directly with the FDA by following the instructions at How to Report Animal Drug Side Effects and Product Problems.
For more detail about the data and studies that the FDA reviewed in its evaluation and approval of Pexion, please see the Freedom of Information Summary.
Pexion is manufactured by Boehringer Ingelheim Vetmedica Inc., of St. Joseph, Missouri.
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.