Zomedica Pharmaceuticals Corp. veterinary pharmaceutical and diagnostic company announced a development update on the company’s four therapeutic candidates for use in companion animals, namely dogs and cats.
ZM-012 and ZM-007: Metronidazole for acute diarrhea in dogs
Development milestones for ZM-012 and ZM-007, complementary oral formulations of metronidazole targeting the treatment of acute diarrhea in dogs 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 9 pounds or 4 kilograms.
- Finalized the oral suspension formulation for ZM-007, which is intended for small breeds and puppies under 9 pounds or 4 kilograms.
- Completed pilot testing for both formulations 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.
A safety study will commence for ZM-012 in the first half of 2018 for completion in the second half of 2018. The company 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.
ZM-006: Transdermal methimazole for hyperthyroidism in cats
Zomedica has finalized its transdermal methimazole formulation for ZM-006, which targets hyperthyroidism in cats. 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.
The company expects to complete pilot testing of ZM-006 in the first half of 2018. If 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.
The company expects to complete pilot testing of ZM-011 in the second half of 2018.
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