Medicinal Cannabis: safe for children with severe epilepsy

14 August 2018
Medicinal Cannabis

Findings into the safety of Epidiolex®, an experimental cannabis-based treatment for severe drug-resistant epilepsy in children, have been published in the Medical Journal of Australia.

Under the NSW Government funded Compassionate Access Scheme, children with the most severe forms of childhood epilepsy, who are too sick to participate in a clinical trial, have an opportunity to access a cannabis-based pharmaceutical-grade medicine, while prioritising safety.

The scheme is the first in Australia to allow children access to medicinal cannabis.

The published findings evaluated the tolerability and safety of Epidiolex®, received through the Scheme by forty children with severe drug-resistant epilepsy as an adjunct to their regular anti-epileptic medications.  Epidiolex® is supplied by GW pharmaceuticals and contains two ingredients: high concentrations of the non-psychoactive ingredient cannabadiol, and low concentrations of psychoactive tetrahydrocannabinol (THC).

The results showed that Epidiolex® is safe and tolerated in children with severe drug-resistant refractory epilepsy. The most common adverse events were sedation and gastrointestinal side effects.

“Thirty-nine patients reported at least one adverse event; many were deemed unrelated to cannabidiol treatment,” reported the authors, led by Dr John Lawson, a paediatric neurologist at Sydney Children’s Hospital, Randwick.

While further studies remain to be done into the effectiveness of Epidiolex® for children with treatment-resistant epilepsy, the findings published incorporated a rating scale where both caregivers and treating physicians rated the general improvement of the child.

“The caregivers of 12 children felt the overall health of their children had much or very much improved; clinicians assessed seven children as being much or very much improved,” Dr Lawson said.

While no patients reported complete seizure freedom, there was stabilisation and in some cases the frequency of seizures was reduced, which is a significant improvement for patients experiencing seizures multiple times per day.

Dr John Lawson, paediatric neurologist at Sydney Children’s Hospital led the CAS across four sites in NSW; Sydney Children’s Hospital, The Children’s Hospital at Westmead, Royal North Shore Hospital and John Hunter Children’s Hospital, Newcastle.  He has also led Australia’s involvement in two international trials of Epidiolex® for the treatment of the epileptic seizures in Dravet Syndrome and Tuberous Sclerosis Complex.

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