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Summary   Objective  Since 2014, cannabidiol ( CBD ) has been administered to patients with treatment‐resistant epilepsies ( TREs ) in an ongoing expanded‐access program ( EAP ). We report interim results on the safety and efficacy of  CBD  in  EAP  patients treated through December 2016.    Methods  Twenty‐five  US ‐based  EAP  sites enrolling patients with  TRE  taking stable doses of antiepileptic drugs ( AED s) at baseline were included. During the 4‐week baseline period, parents/caregivers kept diaries of all countable seizure types. Patients received oral  CBD  starting at 2‐10 mg/kg/d, titrated to a maximum dose of 25‐50 mg/kg/d. Patient visits were every 2‐4 weeks through 16 weeks and every 2‐12 weeks thereafter. Efficacy endpoints included the percentage change from baseline in median monthly convulsive and total seizure frequency, and percentage of patients with ≥50%, ≥75%, and 100% reductions in seizures vs baseline. Data were analyzed descriptively for the efficacy analysis set and using the last‐observation‐carried‐forward method to account for missing data. Adverse events ( AE s) were documented at each visit.    Results  Of 607 patients in the safety dataset, 146 (24%) withdrew; the most common reasons were lack of efficacy (89 [15%]) and  AE s (32 [5%]). Mean age was 13 years (range, 0.4‐62). Median number of concomitant  AED s was 3 (range, 0‐10). Median  CBD  dose was 25 mg/kg/d; median treatment duration was 48 weeks. Add‐on  CBD  reduced median monthly convulsive seizures by 51% and total seizures by 48% at 12 weeks; reductions were similar through 96 weeks. Proportion of patients with ≥50%, ≥75%, and 100% reductions in convulsive seizures were 52%, 31%, and 11%, respectively, at 12 weeks, with similar rates through 96 weeks.  CBD  was generally well tolerated; most common  AE s were diarrhea (29%) and somnolence (22%).    Significance  Results from this ongoing  EAP  support previous observational and clinical trial data showing that add‐on  CBD  may be an efficacious long‐term treatment option for  TRE .

Long‐term safety and treatment effects of cannabidiol in children and adults with treatment‐resistant epilepsies: Expanded access program results