dsm-firmenich has released new clinical data that confirms the bioavailability of its solid CBD-based drug product intermediate, CBtru.
Notably, the ingredient is absorbed into the bloodstream at a similar level to Epidiolex, which is the first and only CBD product to be commercially approved for the pharmaceutical market.
This is the first time a solid CBD formulation has been proven to be as effective as a liquid, oil-based dosage form.
Improving the patient experience
Research into the CBD field has already led to the launch of Epidiolex, which is approved for use in the management of treatment-resistant epileptic syndromes.
However, liquid dosage forms can be troublesome in terms of patient compliance, as accurate dosing is often challenging.
Therefore, dsm-firmenich wanted to develop a more patient-friendly solid oral dosage form that was both soluble and bioavailable — which has proven challenging thus far owing to the low absorption of the active compound in the gut.
To overcome these challenges, dsm-firmenich optimised CBtru's bioavailability to ensure optimal absorption and efficacy.
CBtru displays comparable performance
To find out if CBtru could perform comparably to Epidiolex, dsm-firmenich performed a clinical study investigating the absorption and pharmacokinetic profile of CBtru.
32 healthy subjects were involved in the trial, with each participants receiving both 400mg CBtru and 400mg Epidiolex under fed and fasted conditions, with a two week washout period between treatment.
Plasma CBD concentration was then measured 24 hours post-treatment, revealing that CBtru's bioavailability was as good as the liquid oil-based product in fed state.
However, in the fasted state, CBtru was more bioavailable than Epidiolex.
The study alsoindicated that CBtru may offer a more reliable and consistent uptake, less dependent on food intake, whilst confirming its safety and tolerability. The complete results and analysis are being prepared for publication in a peer reviewed journal.
“These findings represent a significant breakthrough in the CBD space—and the wider pharmaceutical market,” explains Dr Zdravka Misic, Associate Innovation Director Pharma at dsm-
firmenich.
“With the data indicating that CBtru is at least as bioavailable as the market-leading liquid oil-based reference product, we’ve opened new pathways for the development of CBD-based
therapies using solid oral dosage forms. This is truly innovative, because it paves the way for more patient-friendly delivery systems, such as tablets or capsules. These dosage forms help enhance efficacy, while simultaneously increasing patient convenience and compliance."
"What’s more, beyond improving patient experience, this breakthrough could accelerate research in therapeutic areas where CBD has shown potential, such as pain management, inflammation, cancer, diabetes, as well as sleep, mood and psychotic disorders."