CannEpil+ , based on CannEpil, designed by MGC Pharma to treat Refractory Epilepsy, has been approved for import into the UK by the Medicines and Healthcare products Regulatory Agency via its UK distribution and clinical access partner Elite Pharmaco.
CannEpil+ will initially be used to treat ten patients in the UK who suffer from Refractory Epilepsy. MGC Pharma will be providing CannEpil+ free of charge to these patients on compassionate grounds for six months. This is the first time that the UK authorities have approved an Epilepsy treatment that is on a clinical pathway (Phase IIB) containing THC. 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 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.
MGC Pharma said it expects the results from the observational data collection program, together with the fact that CannEpil has historical clinical safety and efficacy data, and a Phase IIb 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.
Roby Zomer, Co-founder and Managing Director of MGC Pharma, 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.”
Gavin Sathianathan, CEO of Alta Flora said: “MGC Pharma have stepped up to the challenge to provide access to life-changing medicine for ten trial patients, and Alta Flora is proud to support the effort to gather data in order to demonstrate that CannEpil+ has the potential to transform the quality of life of families struggling to deal with the consequences of childhood epilepsy syndromes”