Zomedica Pharmaceuticals Corp. has started talks with the U.S. Food and Drug Administration on the company’s third proposed veterinary product: an oral suspension formulated for the treatment of canine diarrhea.
The Investigational New Animal Drug (INAD) application, announced today, follows the filing of paperwork in support of the same anti-diarrheal in tablet form and for a drug that Zomedica has described only as a novel formulation targeting a metabolic disorder in companion animals.
An INAD application is the first step in earning approval of a veterinary product through FDA’s Center for Veterinary Medicine and marks the opening of discussions about a drug development plan.
The diarrhea drugs, code-named ZM-007 and ZM-012, contain the active ingredient metronidazole, an antibiotic found in human medications that is often prescribed to dogs.
“It is commonly recognized that metronidazole is one of the clinical veterinarian’s most preferred anti-diarrheal treatments for dogs,” said Zomedica chief medical officer William MacArthur, MS, DVM. “Our goal with these formulations is to give veterinarians full confidence that the medication they are using to treat their canine patients is indeed safe and effective, rather than relying on data from human trials.”
The liquid formulation, ZM-007, would help veterinarians accurately dose smaller dog breeds and puppies, Zomedica stated.
“With this oral suspension, Zomedica hopes to offset the veterinarian’s reliance on compounding pharmacies for medication supply and bring associated pharmacy revenue back into the veterinarian’s clinic,” the company reported.
The tablet, ZM-012, would “replace the large, bitter-tasting, human-approved generic tablet routinely prescribed by veterinarians,” the company added.
“By taking ZM-007 and ZM-012 through the rigorous [government] approval process, Zomedica intends to validate these drugs as safe and effective for veterinary use in dogs.”
Zomedica, based in Ann Arbor, Mich., was founded in May 2015 and began trading publicly in 2016 on Canada’s TSX Venture Exchange. Yet to take in any revenue, the company reported a third-quarter net loss of $1.04 million as it plowed money into research and development.
The company’s leadership team also includes chief operating officer Stephanie Morley, DVM.