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FDA approves tablet for treatment of canine idiopathic epilepsy

On January 14, the US Food and Drug Administration (FDA) granted conditional approval to KBroVet-CA1 (potassium bromide chewable tablets) for controlling seizures in dogs with idiopathic epilepsy.

Idiopathic epilepsy is a type of seizure disorder without a known cause that affects about 5% of dogs. KBroVet-CA1 works by stabilizing neurons in the central nervous system to reduce the likelihood of a seizure.

Potassium bromide isn’t a new medication, and it’s not even a new treatment for canine idiopathic epilepsy.

First reported as a treatment for epilepsy in people in 1857, potassium bromide and was described as an animal treatment before 1876. Although less common today as a treatment for epilepsy in humans, it’s still used as a primary or add-on anticonvulsant in dogs, decreasing seizure frequency in 72%–74% of epileptic dogs. Although traditionally used in combination with phenobarbital, it’s increasingly being used as a single-agent treatment for dogs with seizures.

Congress granted the FDA a limited expansion of the conditional approval pathway for some new animal drugs under the 2018 reauthorization of the FDA’s Animal Drug User Fee program. Conditional approval allows an animal drug sponsor to legally market its product after demonstrating that the drug is safe and manufactured in accordance with full approval standards, and that there is a reasonable expectation of effectiveness for use.

Per the FDA, KBro-Vet-CA1 meets the criteria of conditional approval, as there’s currently no animal drug approved and marketed in the US for the treatment of idiopathic epilepsy in dogs.

Possible adverse side effects of potassium bromide on dogs include:

  • Vomiting
  • Constipation
  • Increased appetite
  • Lack of appetite
  • Increased thirst
  • Increased urine production

Older animals may have a higher incidence of adverse side effects.

The FDA’s decision marks the second time in a week that the agency has conditionally approved an oral treatment for dogs; on January 11, the FDA conditionally approved Laverdia-CA1 (verdinexor tablets) to treat canine lymphoma.

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