Two new oral medications — one for the control of seizures in dogs with idiopathic epilepsy and the other for the treatment of canine lymphoma — have received conditional approval from the U.S. Food and Drug Administration.
The epilepsy drug, KBroVet-CA1 (potassium bromide chewable tablets), was developed by Pegasus Laboratories Inc., a contract manufacturer and the maker of the PRN Pharmacal brand of veterinary medications.
Given daily, KBroVet-CA1 will be available by prescription only. The active ingredient, potassium bromide, is a halide salt, according to a Freedom of Information Summary, “and when the salt passes through neuronal channels, it hyperpolarizes neuronal membranes and stabilizes the neurons. This reduces the likelihood of a seizure.”
Pegasus is headquartered in Pensacola, Florida.
Meanwhile, Anivive Lifesciences Inc. of Long Beach, California, earned the go-ahead for Laverdia-CA1 (verdinexor tablets), which the FDA described as the first conditionally approved oral treatment for dogs with lymphoma. An injectable lymphoma drug, VetDC’s Tanovea-CA1, was similarly approved in 2016.
Laverdia-CA1 should be administered twice a week, according to the FDA. The medication is expected to hit the veterinary market this spring, Anivive reported on its website.
“Lymphoma is a devastating cancer in dogs, with few FDA-approved treatments available,” said Steven M. Solomon, DVM, MPH, director of the FDA’s Center for Veterinary Medicine.
The conditional approvals followed a move by Congress in 2018 to expand opportunities for veterinary drug developers.
“Conditional approval allows veterinarians to access needed treatments while the drug company collects additional effectiveness data, such as through trials with client-owned dogs,” the FDA noted. “The company then has up to five years to complete effectiveness studies to support a full approval.”
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