Jazz Pharmaceuticals takes groundbreaking epilepsy drug Epidiolex for adolescents into phase III trial

pharmafile | August 19, 2022 | News story | Medical Communications  

The phase III trials will assess Epidiolex over 14 weeks in a randomised, double-blind, placebo-controlled study, enrolling paediatric patients aged 1 to 18. It is hoped that Epidiolex will ease symptoms associated with Doose syndrome (EMAS), a rarer type of childhood-onset epilepsy, accounting for 1-2% of all cases.


Epidiolex, developed by GW Pharmaceuticals, is an epilepsy treatment derived from cannabidiol (CBD), a chemical component of Cannabis. However, it doesn’t include tetrahydrocannabinol (THC), the psychoactive compound Cannabis is more famous for.


Epidiolex was the first cannabis-based drug therapy to be approved by the Food and Drugs Association (FDA) back in 2018. It required a reclassification by the US Drug Enforcement Agency (DEA) before it could be commercialised.


EMAS tends to occur more in boys than girls, and is linked to different types of seizures which include drop, tonic, and myoclonic seizures. Jazz Pharma saw that seizures in paediatric EMAS patients were difficult to treat, with some children reacting badly to currently-recommended medications.


The trial will be split into two portions, the first of which will assess the efficacy and safety of cannabidiol compared to placebo as a treatment for adolescents with myoclonic-atonic seizures. Portion two will be an optional 54-week open-label extension trial.


 “Jazz is committed to continuing to generate clinical study data and real-world evidence to further support the utility of the company’s cannabidiol across a broad range of difficult-to-treat seizure types,” stated Rob Iannone, Executive VP and Global Head of Research and Development of Jazz Pharmaceuticals.


CBD is also purported to be helpful with alleviating symptoms of other medical conditions, such as anxiety, pain, dystonia, Parkinson’s disease, and Crohn disease, according to WebMD. Journal of Clinical Study recently published a study which observed that cannabis-based treatments can reduce anxiety by 50% in adolescents aged between 12-25 who have reacted negatively to other treatments. Other researchers are assessing the use of cannabidiol against inflammation caused by COVID-19.

James Spargo

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