Zomedica Pharmaceuticals Corp., a veterinary pharmaceutical and diagnostic company, today announced a development update on the Company’s four therapeutic candidates for use in companion animals, namely dogs and cats.
“We are pleased that we have achieved the milestones we established earlier this year,” stated Gerald Solensky, Jr., Chief Executive Officer at Zomedica. “2017 was an important year for our pipeline development as we finalized formulations for all four of our lead therapeutic candidates. We look forward to sharing future advancements as development progresses.”
ZM-012 and ZM-007: Metronidazole for acute diarrhea in dogs
ZM-012 and ZM-007 are complementary oral formulations of metronidazole targeting the treatment of acute diarrhea in dogs. Key development milestones achieved for ZM-012 and ZM-007 in 2017 include:
- Finalized novel tablet formulation for ZM-012 to replace the large, bitter tasting human-approved generic tablet commonly prescribed by veterinarians for their canine patients. The beef-flavored oral tablets are intended for dogs greater than nine pounds or four kilograms.
- Finalized the oral suspension formulation for ZM-007, which is intended for small breeds and puppies under nine pounds or four kilograms. According to Brakke Consulting, metronidazole is one of the most frequently compounded drugs for dogs.
- Completed pilot testing for both ZM-012 and ZM-007 at Michigan State University College of Veterinary Medicine to measure metronidazole’s effectiveness to treat acute diarrhea in dogs.
- Scheduled December 2017 pre-submission meeting with the U.S. Food and Drug Administration Center for Veterinary Medicine (FDA-CVM) to present the regulatory strategy and development plan for ZM-012.
Zomedica expects to commence a pivotal safety study for ZM-012 in the first half of 2018 for completion in the second half of 2018.
Zomedica also expects to hold a pre-submission meeting in the first half of 2018 with the FDA-CVM specific to the product development strategy for ZM-007 as a bioequivalent to ZM-012. Drugs that are considered to be bioequivalent are, for regulatory purposes, essentially the same, meaning the absence of significant difference between the extent and rate of absorption over the course of a specific period of time at the same dose and under the same conditions. If deemed acceptable by the FDA-CVM, the implementation of this bioequivalent strategy is contingent on FDA-CVM approval of the new animal drug application (NADA) for ZM-012. If the FDA-CVM permits Zomedica to rely on the bioequivalence of ZM-007 to ZM-012, Zomedica anticipates that this regulatory pathway will conserve significant development costs because a bioequivalence study could replace the need for pivotal safety and efficacy studies for ZM-007.
ZM-006: Transdermal methimazole for hyperthyroidism in cats
Zomedica has finalized its transdermal methimazole formulation for ZM-006, which targets hyperthyroidism in cats, one of the most commonly diagnosed hormone disorders in middle-aged to older cats according to the American Association of Feline Practitioners. Intended for application to the cat’s ear using an applicator pen, the transdermal gel is an alternative to conventional oral tablets already approved by the FDA-CVM for cats. However, according to Brakke Consulting methimazole continues to be one of the most frequently compounded drugs because of the associated difficulties with administering pills to cats.
Zomedica expects to complete pilot testing of ZM-006 in the first half of 2018. Assuming such pilot testing is successful, Zomedica intends to commence and complete a pivotal safety study of ZM-006 in the second half of 2018.
ZM-011: Transdermal fluoxetine for inappropriate urination in cats
Zomedica has finalized its transdermal fluoxetine formulation for ZM-011, which is also intended to be applied to the cat’s ear using an applicator pen. Most commonly known by its human pharmaceutical brand name Prozac®, fluoxetine is frequently prescribed by veterinarians using a human-approved oral tablet or compounded drug to treat feline behavioral disorders such as inappropriate urination1.
Zomedica expects to complete pilot testing of ZM-011 in the second half of 2018.
Based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical and diagnostic company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include innovative therapeutics and diagnostics that emphasize patient health and practice health. With a team comprised of clinical veterinary professionals, 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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1 Kaur, Gagandeep, Victoria L. Voith, and Peggy L. Schmidt. “The Use of Fluoxetine by Veterinarians in Dogs and Cats: A Preliminary Survey.” Veterinary Record Open 3.1 (2016): e000146. PMC. Web. 11 Dec. 2017.