New clinical study validates dsm-firmenich’s CBtru® as a promising pathway for patient-friendly CBD-based therapies

dsm-firmenich, a leading innovator in health, nutrition, and beauty, today reveals new clinical data confirming that the bioavailability of cannabidiol (CBD)-based therapies can be enhanced in oral solid dosage forms. The clinical trial results demonstrated that dsm-firmenich’s CBD drug product intermediate, CBtru®, is absorbed into the bloodstream at a similar level compared to Epidiolex®, the first (and to this date only) commercially approved CBD drug product on the market, which is in a liquid oil-based dosage form. This is the first time that a solid CBD formulation has shown comparable absorption results to the liquid oil-based reference product. With this evidence, 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

How CBtru® can shape the future of modern medicine

Research in the CBD field has already led to the launch of the oil-based drug product Epidiolex®, for the management of treatment-resistant epileptic syndromes. Despite these advances, current oil-based CBD formulations might present notable challenges for patients, including difficulties with accurate dosing and sensory hurdles. Progressing CBD clinical development towards more patient-friendly solid oral dosage forms is key for expanding treatment options and patient convenience. However, these advancements have been restricted by the limited solubility and variable bioavailability of CBD, which can be as low as 6% due to incomplete absorption in the gut and significant pre-systemic elimination in the liver.¹ The solubility and absorption of CBD generally increases when co-administered with a high-fat meal, because lipophilic molecules can dissolve in the fat content of food. As individuals have different diets and mealtimes, this leads to considerable variability in the bioavailability of CBD and increases the potential for sub-optimal CBD efficacy.^2,3,4 To overcome the bioavailability challenge and unlock new drug development innovation, dsm-firmenich developed CBtru®, an innovative formulated CBD drug product intermediate with enhanced bioavailability in a solid powder form with a considerably higher drug loading.

Study reveals: CBtru® matches oil-based CBD bioavailability

To validate the enhanced bioavailability of dsm-firmenich’s proprietary CBD drug product intermediate for use in solid oral dosage forms, a clinical study (NCT06578455) set out to investigate the absorption and pharmacokinetic profile of CBtru® compared to the market-approved reference drug product Epidiolex®, a liquid sesame oil-based formulation of CBD. The randomized cross-over study was conducted in 32 healthy subjects, half of them men and half of them women, 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, where CBtru® was administered in capsules, while the oil-based reference product was given using a 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. The study also indicated 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.

Expanding CBD-based treatment options for patients

“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.”

For more information about CBtru®, please visit here.

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.