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FSD Pharma announced that it has submitted to the US Food and Drug Administration (FDA) an Investigational New Animal Drug Application (IND) for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat Gastrointestinal enteropathy in dogs. The application has been accepted for review.
The proposed trial design is a randomized, double-blind, placebo-controlled, crossover, trial comparing FSD201 (ultramicronized Palmitoylethanolamide (PEA)) dosed twice daily for 30 days to placebo for the treatment of canine inflammatory bowel disease. The primary endpoint will be a validated diarrhea score, evaluated by both treating veterinarian and dog owner. The trial will be conducted at 5-10 sites in the USA, and will enroll up to 200 dogs.
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