For the first time ever, an epilepsy treatment that is currently in the clinical trial process, and which contains THC, has been approved by the authorities in the UK for import.
MGC Pharmaceuticals has been granted a permit for the import of its phytocannabinoid-derived treatment for refractory epilepsy, CannEpil+, into the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
CannEpil+ is a biosimilar effect-identical product of CannEpil, which is a phytocannabinoid treatment for refractory (drug-resistant) epilepsy and will now be available on prescription for patients in the UK.
Epilepsy affects approximately 600,000 people in the UK, and around 50 million people worldwide, with near to 33 per cent of adults, and 20 to 25 per cent of children suffering from refractory epilepsy ,which cannot be controlled with traditional anti-seizure medication. The approval is a welcome move for patients and their families, which have been campaigning to improve access to cannabis-based medicinal products with demonstrated efficacy at treating refractory epilepsy as well as safety.
Landmark prescription approval
The medicine will initially be used to treat ten patients in the UK who suffer from refractory epilepsy and MGC Pharma will be providing it free of charge to these 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 designed to establish a central platform to monitor the safety of treatment in patients globally.
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The company says it expects the results from the observational data collection programme together with CannEpil’s historical clinical safety and efficacy data, and its 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.
“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,” commented Roby Zomer, co-founder and managing director of MGC Pharma.
“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 treatment with CannEpil+ in the coming months.
“The development of our Data Collection App will optimise our understanding of both CannEpil, CannEpil+ and other future treatments, and ultimately provide patients with a better treatment for refractory epilepsy, and therefore improving their quality of life.
“It is also a vitally important foundation for building strong relationships with UK medical regulators and health organisations which will benefit MGC Pharma going forward, as we look to roll out further clinical trials and products in the UK.”
What do doctors and patients need to know?
With the approval, doctors can now issue a prescription for the medicine to both adults and children. The medicine is manufactured under strict EU-GMP conditions, and can currently be provided to patients in countries that allow cannabis based medicinal products – allowing the medicine to be offered to patients at an affordable price.
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MGC has worked with Alta Flora to create a bespoke version of healthcare data platform, the Eva App, to enable researchers and the medical establishment to determine how plant-based therapies improve patient quality of life.
The system captures Patient Reported Outcome Measures which can be used by regulators, manufacturers and clinicians to assess the safety and efficacy of new medicines, and enables the adjustment of measurement protocols in order to meet clinical standards and incorporate other conditions and future observational trials for their treatment.
Alta Flora CEO, Gavin Sathianathan, 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.”
The medicine is currently undergoing Phase IIb, double blind, placebo-controlled trials, which are set to begin in Q3 and Q4 2021 at the Schneider Hospital in Israel and within the NHS in the UK, and is pipelined for Central Market Authorisation in the next two years.
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Robin Emerson COO of Elite Growth Ltd and high-profile Medical Cannabis Advocate commented: “This is a huge step forward for cannabis-based medications in the UK. 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 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.”
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