FDA conditionally approves first oral treatment for canine idiopathic epilepsy, under its expanded authority

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The US Food and Drug Administration announced yesterday the conditional approval of KBroVet-CA1 (potassium bromide chewable tablets, Pegasus Laboratories Inc) to help manage seizures in dogs with idiopathic epilepsy.

The first conditionally approved idiopathic canine epilepsy treatment to be granted under the reauthorized 2018 FDA’s Animal Drug User Fee Act, KBroVet-CA1

stabilizes neurons in the central nervous system to reduce the chances of having a seizure. Available by prescription only, KBroVet-CA1 is administered orally daily.

Potassium bromide has long been used to control canine seizure disorders. However, prior to the FDA’s new authority, no veterinary drug sponsor had applied for approval.

“We are pleased to see animal drug sponsors respond to the expanded conditional approval authority by bringing forward applications to treat serious, life-threatening diseases for which there are no approved therapies available,” says Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine, in this FDA release.

Conditional approval, which is an option for drugs intended for minor use in major species, provides veterinarians with access to necessary treatments while the pharmaceutical company gathers additional efficacy data.

The expanded authority allows for the conditional approval of drugs intended to address “a serious or life-threatening disease or condition, or an unmet health need, but for which demonstrating effectiveness would require complex or particularly difficult studies,” according to the release.

Initial conditional approval is valid for 1 year with the potential for 4 annual renewals. During this period, the drug sponsor must demonstrate that it is actively working toward collecting the remaining effectiveness data to support full approval.

KBroVet-CA1’s reasonable expectation of efficacy was demonstrated in a retrospective study of the medical records of 51 client-owned dogs with idiopathic epilepsy, all of whom were treated solely with potassium bromide at the same dose for at least 60 days to control their seizures.

According to peer-reviewed articles, the most common adverse reactions associated with potassium bromide administration are neurologic (including behavioral changes), gastrointestinal (including inflammation of the pancreas), reproductive, endocrine, dermatologic, and respiratory. Increased thirst and urination may also occur. Dogs with decreased kidney function appear to be at greater risk for bromide intoxication, the signs of which can include depression, behavioral changes, ataxia, hind limb paresis, mydriasis, stupor, and coma.

The FDA advises owners of dogs with idiopathic epilepsy to work closely with their veterinarians to monitor clinical signs to help control potential seizures that may result from bromide intoxication. The agency also recommends avoiding abrupt diet changes in dogs receiving potassium bromide, as this could compromise seizure control or raise safety concerns.

KBroVet-CA1 is available by prescription only.