EP1 – A Breakthrough Treatment for Severe Epilepsy
EP1 is a revolutionary cannabinoid based whole plant treatment breakthrough from better™ for treating Severe Refractory Epilepsy and other forms of drug resistant Epilepsy. The treatment is based on better™’s proprietary “Ph.D.” strain holding a unique ratio of 20:1 (CBD to THC respectively).
In 2014, the Israeli Ministry of Health (“MoH”) approved a large clinical trial conducted in five leading hospital sites to test the efficacy of Medical Grade Cannabis (“MGC”) on 77 children and adolescents.
More than 80% were under 15 years of age) who suffer from the most severe cases of drug resistant Epilepsy (40% of these had previously used 5-10 Anti-Epileptic Drugs [“AED”], 60% used 10 AED’s or more). The majority of these in the trial also suffered from retardation or autism due to their condition.
The delivery method criteria set for the trial was cannabis extract mixed with oil, and applied sub-lingually. Cann Israel (better™) was the leading supplier of the unique CBD to the trial.
The specialised CBD treatment yielded a significant positive effect on seizure load.
Most of the children (66/74) or 89% reported reduction in seizure frequency:
- (13) or 18% reported 75–100% reduction in seizures,
- (25) or 34% reported 50–75% reduction in seizures,
- (9) or 12% reported 25–50% reduction in seizures,
- (19) or 26% reported <25% reduction in seizures.
- (5) or 7% patients reported aggravation of seizures which led to CBD withdrawal.
In addition, improvement was observed in behaviour and alertness, language, communication, motor skills and sleep.
There were no allergic responses. Adverse reactions included somnolence, fatigue, gastrointestinal disturbances and irritability leading to withdrawal of cannabis use in 5 patients. Somnolence and fatigue were relatively common but they were mostly temporary.
There were no major systemic side effects, and the reported gastrointestinal problems were of minor significance.
Differentiating Factors: The Israeli MoH trial was a large retrospective study. It differs from the previously reported studies in a number of aspects.
Conclusions: The results of this multi-centre study on CBD treatment for intractable epilepsy in a population of children and adolescents are highly promising.
Cann Israel Breakthrough
better™ tested the hypothesis that its EP1 Ph.D treatment if used with its medical vaporiser delivery system could relieve severe seizures even faster.
Using this delivery method, seizures amongst all patients ceased in a matter of seconds. That combination was also found to be highly efficient among the most severe patients who did not respond as expected to the oral treatment.
The consistency and stability of the Ph.D. strain in delivering the same 20:1 ratio in combination with better™’s medical vaporizer delivery system within each treatment was found to provide the breakthrough – an immediate and higher bio-availability of active compounds in the patient’s plasma.
Based on the encouraging trial results in 2015, the MoH issued a historic decision adding epilepsy to the approved list of medical conditions treated with MGC.