The UK’s Medicines and Healthcare Products Regulatory Agency has granted Perth-based medical cannabis company MGC Pharma (ASX: MXC) a license to import cannabis medicine CannEpil+.
CannEpil+ is a medication used to treat refractory epilepsy (a form of epilepsy that traditional seizure medications don’t work on). Currently, an estimated 600,000 people in the UK have epilepsy and approximately 33% of adults and 20 – 25% of children with epilepsy have refractory epilepsy. Cannabis medicines have previously proved very effective in managing refractory epilepsy, though the stigma against cannabis has made the treatment controversial.
MGC Pharma has been granted an export license to bring CannEpil+ to the UK because the UK has an “urgent need” for it. Although medical cannabis is legal in the UK, the industry is very strictly controlled. This will be the first time the UK has allowed a company to import a THC-containing medication during a Clinical Trial.
MGC Pharma will give free CannEpil+ to ten people who have refractory epilepsy on “compassionate grounds” for six months. These people will also participate in a new clinical trial that will monitor how well the drug works.
As part of the trial, the participants will track their experiences with the Eva App. The app will capture Patient-Reported Outcome Measures (PROMS), which regulatory bodies, researchers and doctors will monitor. If the trial is successful, it could pave the way for people with refractory epilepsy in the UK to access the medication through their neurologists and GP’s.
According to MGC Pharma’s co-founder and managing director Roby Zomer, the approval of CannEpil+ puts the company one step closer to its goal of bringing the medication to people who need it.
The approval of for the import of CannEpil+ to the UK and the associated compassionate prescriptions is an important step towards our global rollout process of the treatment and our continued commitment to patients.
The company expects to have the medication in the UK in the next few months, and the clinical trial will begin shortly after. MGC Pharma will import CannEpil+ into the UK through its partner Elite Pharmaco.