In March 2016, our phase 1 clinical study was completed which highlighted the considerably higher bioavailability of CBD when administered via Satipharm's CBD Gelpell® capsules in comparison to an oromucosal formulation in humans. These results are now published in Clinical Pharmacology in Drug Development (“CPDD”), an international peer-reviewed medical journal:
“Single-Dose Pharmacokinetics of Oral Cannabidiol Following Administration of PTL101: A New Formulation Based on Gelatin Matrix Pellets Technology”
Phase 2 Clinical Trials
In July 2018, we completed our phase 2 clinical study to test Satipharm’s proprietary CBD Gelpell® capsules in sixteen paediatric patients with very severe, uncontrolled, treatment-resistant epilepsy. This prospective, open-label study demonstrated a marked therapeutic effect of a 12-week treatment period on seizure frequencies among the trial patients.
A mean 73.4% reduction from baseline monthly seizure frequencies was observed, with two patients fully seizure-free within 5 weeks of treatment, while an additional seven patients reported >50% seizure frequency reduction.
This result was achieved with a safe product that does not contain the psychoactive cannabinoid THC. This is an important consideration for a treatment where patients may need to take the treatment for some months or years.
The full phase 2 trial results will be published in due course.