Insys Therapeutics Successfully Completes Safety and Pharmacokinetic (PK) Study of Cannabidiol Oral Solution in Pediatric Epilepsy Patients
Insys Therapeutics, Inc. (NASDAQ: INSY) (“Insys” or “the Company”) today announced that it has successfully completed its Phase 1/Phase 2 safety and pharmacokinetic (PK) study in pediatric subjects with treatment-resistant epilepsy.
In this trial, 61 subjects with refractory epilepsy, between the ages of 1 year to 17 years, received treatment with Insys’ pharmaceutical cannabidiol (CBD) oral solution across multiple investigative sites in the United States. The clinical trial evaluated multiple ascending doses of Insys’ CBD with three cohorts of subjects receiving total daily doses of 10 mg/kg, 20 mg/kg or 40 mg/kg. Over 80% of these subjects continue to receive CBD in an ongoing long-term safety study.
“We are excited that our synthetic pharmaceutical CBD in a non-alcoholic, medium chain triglyceride-based formulation was studied up to a daily dose of 40 mg/kg in subjects with pediatric epilepsy. The data is currently under analysis, and the CBD appears to have been...
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