Refractory epilepsy drug CannEpil+ has been approved for import into the UK by the Medicines and Healthcare Regulatory Agency (MHRA) ahead of a small-scale clinical trial.
Doctors can now prescribe the drug to adults and children across the country.
This is the first time a THC-containing epilepsy drug has been approved for import during the clinical trials process in the UK.
CannEpil+, developed by bio-pharma brand MGC Pharmaceuticals and distributed via Elite Pharmacy, will be prescribed to 10 patients for a six-month period free of charge.
The patients’ data will be monitored during the trial using an app provided by Alta Flora.
The app will provide the MHRA and doctors with data on the efficacy of the THC-containing drug, potentially leading to wider prescription across the UK.
MGC Pharma MD and co-founder, Roby Zomer, said:
“The approval for the import of CannEpil+ to the UK and the associated compassionate prescriptions is an important step towards our global roll out of the treatment, and our continued commitment to patients.
“Achieving MHRA approval has been an ongoing process for some time with our UK partner Elite Pharmaco, and we expect the first patients in the UK to begin treat with CannEpil+ in the coming months.”
The MHRA approved the import license in response to the urgent need of patients to access a clinical product that can demonstrate efficacy and safety in treating refractory epilepsy.
Refractory or drug-resistant epilepsy affects 20-30% of the UK’s more than 600,000 epilepsy sufferers.
The medical cannabis campaigner referred to the move as ‘a huge step forward for cannabis-based medications in the UK
“As a father of a 5-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 how 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.”Robin Emerson