FSD Pharma´s Covid treatment receives FDA approval

The FDA has approved FSD Pharma (Nasdaq: HUGE) Phase 2 study of FSD201 (ultramicronized palmitoylethanolamide, or ultramicronized PEA) for the treatment of hospitalized COVID-19 patients. Patient dosing is expected to start in October. The study with 352 subjects will examine the efficacy and safety of FSD201 at a dose of 600 mg or 1200 mg twice daily together with the standard treatment ((SoC)) for a treatment duration of 14 days. The primary aim of the study is to determine whether FSD201 plus SOC leads to a significant improvement in the clinical status of patients (e.g. shorter time to symptom relief) after 28 days. Shares were up 16% ahead of the launch.