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FDA approves generic clomipramine to treat separation anxiety in dogs

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Treating an anxious dog? Now you have options you didn’t have before.

On October 30, the US Food and Drug Administration’s Center for Veterinary Medicine approved the first generic form of clomipramine hydrochloride tablets for use in treating separation anxiety in dogs.

Separation anxiety is a serious problem in dogs, and its effects go beyond barking, soiling the floors, or chewing on things: Separation anxiety is one of the main reasons owners get frustrated with their dogs and give them up for rehoming.

Separation anxiety occurs when a dog fears or has underlying anxiety about being left alone. In a survey of factors associated with surrendering dogs to a humane society, 3 out of 10 of the most commonly reported problems were consistent with separation anxiety.

Clomipramine reduces the clinical signs of separation anxiety by increasing brain serotonin levels to balance out mood. Separation anxiety affects an estimated 20%–40% of dogs treated by veterinary behaviorists.

NEWStat reached out to Karen L. Overall, VMD, PhD, MA, DACVB, editor-in-chief of Journal of Veterinary Behavior: Clinical Applications and Research, and a senior research scientist in the biology department at the University of Pennsylvania, to find out more.

“Clomipramine was the first licensed medication for the treatment of any behavioral condition in dogs, and has been a boon for dogs affected with separation anxiety,” Overall said. The medication is also used extralabel to treat obsessive-compulsive disorder (OCD) and other anxiety-related conditions in dogs and cats.

Overall said a generic version could be a game-changer because, historically, there have access problems with clomipramine, which is also used to treat OCD in humans: “The human generic used be inexpensive and is now priced beyond the [means] of most veterinary clients.” And because Clomicalm, the brand name version used to treat animals, is too expensive for most veterinarians to stock on a regular basis, their clients often shop for it online themselves—with “mixed results,” Overall said.

Occasional production issues leading to periodic shortages are another concern.

But Overall cautions that how well the generic goes over will depend, in part, on the cost. “If pricing is reasonable—and this is important because long-term treatment with behavioral medication is the rule—this is a medication that would be a first-line choice for many behavioral conditions,” Overall said.

That’s assuming the behavior conditions are diagnosed in the first place. Overall says that few veterinary schools offer clinical programs in veterinary behavioral medicine. And that’s a problem because behavioral problems are the one class of problems that determine lifespan in dogs and retention in the household. “Behavior is the core discipline which contributes to the pathology and clinical signs of all other conditions and the ability to recognize, diagnose and treat those conditions.”

Overall says that while separation anxiety is among the most commonly diagnosed behavioral concerns, she also believes that behavior conditions are underdiagnosed because relatively few veterinarians have adequate training in veterinary behavioral medicine.

Assuming that veterinarians have the training to recognize a behavioral problem, take a history, and have the freedom to intervene, Overall says, “generic clomipramine will be invaluable to them.”

But she points out that studies have shown clomipramine works, in part, by facilitating the rate at which behavioral modification is acquired. “This drives home the importance of adequate knowledge in the field and treating the whole dog or cat by also addressing social and environmental triggers and interventions.”

Overall is especially pleased that the new generic will be available in a 5-milligram cat-size tablet.

“Not having to compound a product makes it much more accessible for the cats and small dogs who need it.”

Photo credit: © iStock/Phil Lewis