DUSSELDORF, GERMANY — The administration of oral, synthetic THC (dronabinol) is safe and effective for the treatment of refractory spasticity in pediatric patients, according to clinical data published online ahead of print in the European Journal of Pediatric Neurology.
Researchers from the University of Dusseldorf in Germany assessed the palliative treatment of dronabinol in 16 adolescent subjects with complex neurological conditions. Subjects received dosing twice daily and the median duration of treatment was 181 days.
Oral THC administration was associated with reduced spasticity in the majority of subjects treated. No serious or enduring side effects were reported. “Our data show evidence that dronabinol can effectively be administered over a longer period of time to … young children … without severe side effects or aggravation of pre-existing concurrent conditions,” authors concluded.
The study is one of the first trials to specifically assess the safety and efficacy of THC in an adolescent patient population.
The US Food and Drug Administration approved the prescription use of oral, synthetic THC as an anti-emetic and as an appetite stimulant in the mid 1980s. A liquid version of dronabinol was FDA approved for similar purposes earlier this year.