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.
About Zomedica
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.
Follow Zomedica
- Email Alerts: http://www.zomedica.com/investor-information/
- LinkedIn: www.linkedin.com/company/zomedica
- Facebook: https://www.facebook.com/zomedica/
Reader Advisory
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the release.
Except for statements of historical fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
Forward-looking information is based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection and the other risk factors disclosed under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.