A drug derived from cannabis offers new hope to people with untreatable forms of epilepsy, according to the results of a new study.
The cannabidiol compound reduced convulsive seizures by almost 40% in teenagers and children with Dravet syndrome — one of the most difficult types of epilepsy to treat. In 5% of cases, the debilitating fits afflicting some patients every day stopped altogether.
The drug’s manufacturer, GW Pharmaceuticals, based in Britain and the US, funded the trial, which was carried out by independent researchers.
The compound has been given the brand name Epidiolex, and the company expects to apply to the European Medicines Agency for approval later this year.
In the EU, a company may submit an application via the centralised procedure to the EMA for a single marketing authorisation. If approved, the authorisation is valid in all EU states.
GW chief executive Justin Gover said they want to make the medicine available as quickly as possible.
The State’s medicines watchdog, the Health Products Regulatory Authority, participates in assessment of applications for medicine authorisations at the EMA.
The drug’s full potential could be much bigger if future research shows it can control symptoms of other forms of epilepsy in both children and adults.
Cannabidiol (CBD) is a medical-grade cannabis extract containing virtually no high-inducing psychoactive chemicals.
A total of 120 children and teenagers, aged 2-18 were recruited for the study, published in The New England Journal of Medicine.
For those given the cannabis drug over 14 weeks, the typical number of convulsive seizures suffered every month halved from around 12 to 6. Those experiencing at least a 50% reduction in the frequency of convulsive seizures was 43% for the CBD group and 27% for the placebo group.
Side-effects were said to be mild or moderate in severity, most commonly involving vomiting, fatigue, and fever. Eight patients from the CBD group and one taking the placebo dropped out of the trial because of side-effects.
Experts still do not understand precisely how the compound controls epilepsy symptoms — it is thought to work on a network of molecular receptors in the brain and nervous system.
Cork woman, Vera Twomey wants access to a different form of medicinal cannabis for her daughter, Ava, aged 7.
She explains: "We were offered a trial of Epidiolex about two and a half years ago.
We were very excited at the time about the trial. But unfortunately, or fortunately, as it turned out we lost our place on the trial to a child from England."
Ms Twomey, from Aghabullogue, County Cork, said the particular form of the drug at the centre of the study two and a half years ago would have been unsuitable for Ava because of the side-effects: “We are looking for medicinal THC to complement the medicinal CBD that she is on on the moment."
Last month Ms Twomey was stopped at Dublin Airport attempting to bring medicinal cannabis into the country from Barcelona. She said of Ava: “She has gone through 11 other different forms of medications to treat her seizures, all of which have been unsuccessful. She is reasonably well at the moment but has suffered a number of seizures in the last couple of days.”
People Before Profit Alliance TD Gino Kenny, who has put forward the Cannabis for Medical Use Regulation Bill, said it is with the parliamentary legal office. He is not optimistic it will go further: “I just want to help people like Vera and the cannabis access programme that the Government favours is quite restrictive.”
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