- Epidolex, a liquid form of cannabidiol – an active ingredient in cannabis – is undergoing FDA authorization testing
- Children with severe epilepsy had fewer seizures after taking the drug
- Offers to hope to those whose condition is resistant to other treatments
Children with severe epilepsy have significantly fewer seizures when treated with a prescription derivative of marijuana, researchers revealed.
Epidolex – a pharmaceutical liquid form of cannabidiol, an active ingredient in marijuana – is currently undergoing US Food and Drug Administration-authorized phase 3 testing.
Three studies presented at the American Epilepsy Society’s annual meeting showed the drug to be effective on children with treatment-resistant forms of epilepsy.
Dr Orrin Devinsky of New York University Langone Medical Center, lead author of the study, said: ‘We are pleased to report these promising data on significant numbers of children.
‘These data reinforce and support the safety and efficacy we have shared in previous studies.
‘Most important it’s providing hope to the children and their families who have been living with debilitating seizures.’
A study found that Eipdolex – a pharmaceutical liquid form of a type of cannabis – is an effective treatment on children with severe epilepsy. Participants had a median 45% seizure reduction after three months on the drug
The largest study included 261 participants – predominantly children – with an average age of 11.
The participants were given Epidiolex in gradually increasing doses over the course of 12 weeks – in addition to their regular anti-epileptic drug regimen.
Following three months of treatment, the frequency of seizures in all participants was reduced by a median of 45 per cent.
Additionally, almost half – 47 per cent – of the study participants experienced a 50 per cent or greater reduction in seizures.
Furthermore, nine per cent of patients reported being seizure-free after treatment.
Meanwhile, another study explored the long-term efficacy of Epidiolex.
It was authored by Dr Michael Oldham – formerly of the University of California San Francisco and currently of the University of Louisville.
Dr Oldham followed a subset of 25 children – with an average age of nine – for one year.
The children took cannabidiol, in addition to their regular anti-epileptic drug regimen.
After 12 months, treatment with cannabidiol resulted in a 50 per cent reduction in seizures for 10 participants.
Additionally, 12 of the children discontinued the use of cannabidiol because it did not work for them.
One of the youngsters experienced had an increase in seizure frequency because of the cannabidiol.
Dr Oldham said: ‘The [cannabidiol] as an add-on therapy reduced seizures by half for a third of the patients in the first 12 weeks of the study.
Four studies presented at the American Epilepsy Society’s annual meeting explored the efficacy and long-term effects of the drug – which is said to help children who are reisistant to common anti-epileptic drugs
‘The substantial improvement was maintained by 40 per cent of the participants for the entire 12-month period showing strong promise that [cannabidiol] can be effective in controlling seizures.’
The third pre-clinical study found that cannabidiol exerted ‘significant anticonvulsant effects’ and was well-tolerated in rodents.
That study was provided as a free service by the National Institute of Neurological Disorders and Stroke ASP, and was conducted by the University of Utah.
A fourth study, also in animals, explored how cannabidiol interacts with existing anti-epileptic drugs in animal models of seizures.
It helped determine the effects of cannabidiol in combination with common anti-epileptic drugs, including carbamazepine, valproate, levetiracetam, clobazam and lacosamide
That study was led by Dr Misty Smith of University of Utah.
Dr Smith said: ‘We are gaining a better understanding of the nature of these interactions.
‘This will help optimize therapeutic safety and efficacy for [cannabidiol] moving forward.