In an announcement released on the ASX, Cann Group has plans to move forward with Phase III clinical trials for their cannabis-based Satipharm CBD capsules, with the aim of ‘securing an approval by the end of calendar year 2022’.
As far as we’re aware, no other company has announced time frames for getting the first medicines approved under the TGA’s down scheduling of 150mg/day CBD medicines. The change was effective on the 1st of February 2021, but approval and clinical study requirements meant no actual medicines were available for sale in pharmacies without a prescription. Cann Group aims to be one of the first on the shelves.
Phase 1 and Phase II clinical trials have been completed, with both showing promising results for their Satipharm CBD 50mg capsules.
Phase I clinical trial of the Satipharm CBD capsules in which results demonstrated the safety and high performance of the oral capsule technology, including the superior delivery profile of cannabidiol (CBD) compound to trial subjects. Phase II clinical trial of the Satipharm CBD capsules showed significantly reduced monthly seizure frequency in the treatment of children suffering from refractory, or treatment-resistant epilepsy when the Satipharm capsules were added to current medications. The treatment was generally well tolerated and the median reduction in seizures was 81.9% following 12 weeks of treatment.
The Phase III clinical trial will centre around producing data that ‘supports regulatory approval by the Therapeutic Goods Administration (TGA).
Cann Group’s CEO Peter Crock stands firmly behind the medicine and believes it will benefit a wide variety of Australians.
Cann’s unique formulation and delivery platform enables us to develop a CBD-only product that has superior stability and bioavailability properties and a medicine presentation that will be familiar to consumers and pharmacists.
Satipharm is already sold over-the-counter in pharmacies and health food retailers across the United Kingdom.