Refractory epilepsy treatment containing THC approved for UK import

A new refractory epilepsy treatment, containing THC, has been approved for import into the UK for the first time.

A new cannabis treatment for refractory (or drug-resistant) epilepsy, containing THC, has been approved by the Medicine and Healthcare products Regulatory Agency (MHRA) for import into the UK. 

This is the first time that the UK authorities have approved for import an epilepsy treatment containing THC, which is on a clinical pathway (Phase IIB).

CannEpil+ which is produced by European based MGC Pharmaceuticals, will initially be used to treat 10 patients in the UK who suffer from the condition.

MGC Pharma will be providing CannEpil+ free of charge to these patients on compassionate grounds for six months. 

Now officially approved for import into the UK, a doctor can issue a prescription for CannEpil+ for both adults and  children.

The approval to import CannEpil+ into the UK is in response to the urgent need of some patients to have access to a clinical  product which has demonstrated its efficacy at treating refractory epilepsy, as well as its safety. 

Once the first 10 patients have commenced their treatment, CannEpil+ will undergo an observational trial with data being entered into a data collection app designed to establish a central platform to monitor the safety of treatment in patients  globally.  

Refractory epilepsy affects approximately 33 percent of adults and 20-25 percent of children suffering from epilepsy. In the UK, around 87 people are diagnosed with epilepsy in the UK every day.

MGC Pharma’s biosimilar effect-identical product, CannEpil has historical clinical safety and efficacy data.

It is expected that this, combined with the results from the observational study, and a further clinical trial that is currently under negotiation with a UK NHS facility, will provide specialist neurologists and general practitioners with the confidence to prescribe  CannEpil and CannEpil+ to patients in urgent need of treatment. 

Further Phase IIb randomised, double blind, placebo-controlled clinical studies on the drug are expected to begin in the final part of 2021, following negotiations. 

This will take place at the Schneider Hospital in Israel and within the NHS in the UK. It will focus on the safety and efficacy of CannEpil+ as a supplementary treatment in children and adolescents with refractory epilepsy. 

“This is a huge step forward for cannabis-based medications in the UK,” commented Robin Emerson, COO of Elite Growth Ltd and high-profile medical cannabis advocate. 

“As a father of a five-year-old girl I have witnessed first-hand how Jorja’s  life has been transformed by the use of a Cannabis based medication that contains THC. 

“With this product approval, patients that have tried everything else now have a product with some level of safety and efficacy for the treatment of  epilepsy that can be prescribed by their physician. 

“With the ongoing clinical trial portfolio that MGC Pharma have  developed, including a near term UK NHS based trial, we are answering the call of clinicians in the UK who are asking  for safety and efficacy data. The CannEpil+ programme we are executing will go a long way to moving cannabis-based  medications toward greater adoption and acceptance, opening up much needed access for patients in the UK.” 

Matt Hughes, co-founder of charity Medcan Support, whose son Charlie is prescribed medical cannabis for refractory epilepsy, told Cannabis Health: “This is great and welcomed news, we hope this helps families involved and builds on the current evidence base which already shows the use of THC is well tolerated, effective and safe under clinical guidance.”