The TLR show that both MGC-ODT and Sativex® administration had comparable mean times of peak concentration, half-life and elimination rates for each of the three analytes (THC, THC metabolite 11-hydroxy-THC and CBD). The results indicated dose-related comparability of both products in rate of absorption and bioavailability. The incidence of treatment related adverse events (AEs) were similar between the treatments.
Top Line Results Conclusions: OWC- Orally Disintegrating Tablet is safe to use and appears to have similar PK and bioavailability as Sativex®. Therefore, OWC intends to apply to the Israel Ministry of Health to obtain necessary approvals to market its Medical Grade Cannabis - Orally Disintegrating Tablets in Israel.
If this is ultimately approved by the US FDA, look out.............