Swiss-Dutch health and nutrition company dsm-firmenich has shared new clinical data confirming that the bioavailability of cannabidiol (CBD)-based therapies can be enhanced in oral solid dosage forms.
The pharmacokinetic study results demonstrated that dsm-firmenich’s CBD drug product intermediate, CBtru, is absorbed into the bloodstream at a similar level compared to Jazz Pharmaceuticals' Epidiolex, which is in a liquid oil-based dosage form. The FDA approved Epidiolex in 2018 for the treatment of seizures associated with two rare and severe forms of epilepsy. It is the first FDA-approved drug that contains a purified drug substance derived from marijuana.
dsm-firmenich’s randomized cross-over study was conducted in 32 healthy subjects, aged between 19 and 55. The study design involved four treatment phases, with each participant receiving both CBtru and Epidiolex under fed and fasted conditions, separated by a washout period of two weeks every time. The dose level was 400 mg CBD; CBtru was administered in capsules, while the oil-based reference product was given via syringe. The plasma concentration of CBD was analyzed over 24 hours post treatment, revealing that the bioavailability of CBtru was as good as that of the liquid oil-based reference product in fed state, whereas in the fasted state CBtru demonstrated higher bioavailability than the reference product.
According to dsm-firmenich, the trial represents the first time that a solid CBD formulation has shown comparable absorption results to the liquid oil-based reference product. With this evidence, dsm-firmenich believes that CBtru presents a new opportunity for pharmaceutical companies to develop solid oral CBD-based therapies, offering patients a more convenient and user-friendly alternative to current oil-based medicines.
The complete results and analysis are being prepared for publication in a peer reviewed journal.