ANN ARBOR, Mich., Jan. 30, 2017 (GLOBE NEWSWIRE) – Zomedica Pharmaceuticals Corp. (TSX-V: ZOM), a veterinary pharmaceutical and health care solutions company, today announced that it opened its fourth Investigational New Animal Drug (INAD) application with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) for ZM-011, a transdermal behavioral medication to reduce inappropriate urination in cats. Both ZM-011 and the previously announced ZM-006 use the same transdermal gel technology for their feline-specific formulations.
ZM-011: TRANSDERMAL FLUOXETINE
The active pharmaceutical ingredient for ZM-011 is fluoxetine, most commonly known as Prozac®, its human pharmaceutical brand name. While the FDA-CVM has not approved fluoxetine for use in cats, veterinarians frequently prescribe its human-approved counterpart to treat feline behavioral disorders such as inappropriate urination.
Understanding the inherent challenges with orally dosing cats, ZM-011 is a novel transdermal gel for application to the cat’s ear. This route of delivery aims to maximize patient compliance and efficacy and replace the human-approved oral or compounded drug veterinarians rely on today to treat cats. Zomedica anticipates initiating a pilot study for ZM-011 in 2017.
ZM-006: TRANSDERMAL METHIMAZOLE
Zomedica’s previously announced ZM-006 uses the same transdermal gel to deliver its active pharmaceutical ingredient methimazole, commonly used in veterinary medicine to treat the metabolic disorder hyperthyroidism in cats. Hyperthyroidism (overactive thyroid) is the most commonly diagnosed hormone disorder in middle-aged to older cats and, if left untreated, may have detrimental effects such as weight loss, abnormal appetite, and heart problems.
Transdermal delivery of methimazole is an alternative to conventional oral tablets already approved by the FDA-CVM for cats. Because of the associated difficulties with administering pills to cats, methimazole continues to be one of the most frequently compounded drugs in other dosage forms. With ZM-006, Zomedica aims to offset the veterinarian’s reliance on compounding pharmacies for medication supply and bring associated pharmacy revenue back into the veterinarian’s clinic. Zomedica expects to finalize formulation work in the first half of 2017 and commence a pivotal efficacy trial in the first half of 2018 for ZM-006.
“It’s very common for veterinarians to rely on human-approved drug formulations as well as data from human trials to treat their pet patients,” stated Zomedica’s Chief Medical Officer William MacArthur, MS, DVM. “With our transdermal formulations, we hope to offer veterinarians an affordable FDA-CVM approved option in a dosage-form-of-choice for cats to elevate safety, efficacy and patient compliance.”
In keeping with Zomedica’s veterinarian-focused mission, ZM-011 and ZM-006 advances its innovative drug delivery technology while developing feline-specific drug formulations that maximize patient care and practice performance by keeping treatment regimens affordable. The FDA-CVM requires the use of animal approved drugs when available over human-approved drugs in veterinary species.
With U.S. operations based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical and health care solutions company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica is developing a diversified portfolio to include innovative drugs, drug-delivery technologies, diagnostics, and devices. With multiple clinical veterinarians in executive management, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.
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