New Clinical Study Demonstrates Comparable Bioavailability of CBD in Solid Oral Formulation

Image courtesy of dsm-firmenich

In a February 20, 2025, press release, Swiss-Dutch company dsm-firmenich announced results from a clinical study on its CBD drug product intermediate, CBtru. The study, “A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions,” sought to confirm the bioavailability of the solid oral dose of CBD, as compared with Epidiolex, the only marketed CBD drug approved by the US Food and Drug Administration and Health Canada, commonly used to manage some types of epilepsy (1). The CBtru, formulated in a solid powder, demonstrated comparable absorption in the bloodstream as that of the liquid-oil based formulation, reportedly the first time a solid CBD formulation has done so.

As noted in the press release, challenges with oil-based formulation include accuracy with dosing and sensory difficulties in patients, though obstacles encountered with alternative formats include solubility and variability of the CBD. Even with the addition of high-fat meals with administration, patients can still face variability in the bioavailability and decreased efficiency of CBD as a result. In response, CBtru was formulated with increased bioavailability and drug loading, in solid powder form.

The randomized cross-over study involved 32 healthy participants ages 19 to 55, half were men and half were women. Over four treatment phases, participants received 400 mg of CBD, with CBtru administered via capsules and the Epidiolex via syringe, under both fed and fasted conditions. A two-week washout period occurred between each phase. Over 24 hours post treatment, plasma concentrations of CBD were analyzed. The analysis indicated that, in the fed state, the bioavailability of CBtru was comparable to that of the oil-based formulation. In the fasted state, the bioavailability was higher than the oil-based product. In addition, the study also indicated the safety and tolerability of CBtru.

The results of the study have important implications. “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, in the press release. “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.”

The full results and analysis of the study are in preparation for publication in a peer-reviewed journal.

Reference

1. Clinicaltrials.gov. A Pharmacokinetic Study to Compare CBD-NE to Epidyolex in Healthy Adult Volunteers Under Both Fed and Fasted Conditions. https://clinicaltrials.gov/study/NCT06578455#more-information (accessed Feb 20, 2025).