As part of this process, CannEpil+ has been approved for prescription for patients in the UK
MGC Pharmaceuticals has been granted a permit to import its refractory epilepsy treatment into the UK.
CannEpil+ has been approved for UK import by the Medicine and Healthcare products Regulatory Agency, which was facilitated by its UK distribution and clinical access partner, Elite Pharmaco.
As part of this process, CannEpil+ has been approved for prescription for patients in the UK. This marks the first time UK authorities have approved an epilepsy treatment that contains tetrahydrocannabinol (THC).
Epilepsy affects around 600,000 people in the UK and roughly 50 million people worldwide, with nearly 33 per cent of adults suffering from refractory epilepsy which cannot be controlled with traditional anti-seizure medication.
CannEpil+ will initially be used to treat 10 patients in the UK who suffer from refractory epilepsy. The treatment will be provided free of charge to patients on compassionate grounds for six months.
Once the patients have started their treatment, CannEpil+ will undergo an observational trial with data being entered into a data collection app. The app has been designed to establish a central platform to monitor the safety of treatment in patients globally.
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, co-founder and Managing Director of MGC Pharma Roby Zomer said.
The company said it expected that the results from the observational data collection program would provide specialist neurologists and general practitioners confidence to prescribe the treatment to patients in urgent need of help.
The company believes the approval comes 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.
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