The FDA has approved potassium bromide chewable tablets (KBroVet) for managing canine idiopathic epilepsy.
The FDA announced earlier today that it has granted full approval to potassium bromide chewable tablets (KBroVet; Pegasus Laboratories) for controlling seizures in canine patients with idiopathic epilepsy. These tablets are administered orally daily and are only available by prescription due to the professional veterinary expertise required to diagnose idiopathic epilepsy and to monitor for safe use and any adverse reactions to the medication.
For patients with idiopathic epilepsy, it is important that clients work closely with their veterinary team to monitor clinical signs to help avoid bromide intoxication, which can occur when high levels of bromide overwhelm the nervous system. The FDA also warned clients that it is important to avoid abrupt changes in their dog’s diet if they are receiving potassium bromide because it could raise safety concerns or compromise seizure control.
Patients with severe bromide intoxication may present with following1:
In January 2021, these potassium bromide chewable tablets received conditional approval, making them the first drug conditionally approved under the FDA’s expanded conditional approval authority for certain new animal drugs that are not intended for a minor use or minor species (expanded conditional approval).1 The expanded conditional approval allows for conditional approval of treatment options that are intended to address a serious or life-threatening condition or disease, or meet an unmet health need, but which demonstrate effectiveness would require complex or particularly difficult studies. The potassium bromide chewable tablets met the criteria for expanded conditional approval because, at the time, there were no approved or marketed drugs for idiopathic epilepsy, which affects 5% of the population and is a serious condition that can be life-threatening.
Products that receive conditional approval are valid for 1 year and have potential for up to 4 annual renewals. Within this time frame, the animal drug sponsor must demonstrate active progress toward substantial evidence of effectiveness to receive full approval. The animal drug sponsor has 5 years from the date of conditional approval to obtain full approval from the FDA, or the drug can no longer be marketed.
If a patient has bromide overdose, which can happen if the patient ingests too much of their own medication, they could present with the following symptoms:2
After 4 annual renewals, the drug’s sponsor, Pegasus Laboratories, generated the required effectiveness data to support full approval.
Idiopathic epilepsy is a neurological disorder characterized by recurrent seizures that have no identifiable underlying cause. Although their cause is unknown, a genetic cause is known in some breeds and suspected in others. For dogs with idiopathic epilepsy, they typically begin between 6 months and 6 years of age, with a median age of onset of 2.5 years.3 How often they have seizures can vary widely, with some experiencing them daily and some possibly going weeks, months, or even years without any seizure activity.
Epilepsy is more common in purebred dogs, including beagles, border collies, cocker spaniels, Labrador retrievers, golden retrievers, and more. Additionally, males are more predisposed to idiopathic epilepsy than females.3
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