HUGE - FSD Pharma submits FSD201 IND to treat gastrointestinal enteropathy in dogs
FSD Pharma (HUGE) announces that it has submitted an Investigational New Animal Drug Application ((IND)) to the U.S. FDA for the use of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) to treat gastrointestinal enteropathy in dogs.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.Shares down nearly 2% premarket.
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FSD Pharma submits FSD201 IND to treat gastrointestinal enteropathy in dogs