Pharmacy Daily | S3 CBD med in pipeline

CANNABIS drug development company, BOD Science, is confident its low dose CBD product for insomnia is progressing to become Schedule 3 in Australia.

The company has announced that its phase IIB clinical trial for a new Schedule 3 CBD product for the Australian market is being undertaken by the Woolcock Institute.

One of the first in Australia, the trial assesses the efficacy of a Schedule 3 (Pharmacist Only) CBD formulation on symptoms associated with insomnia in 198 participants over eight weeks.

Completing a major milestone in the study, the trial screening has ended with randomisation expected to be completed by the end of the month (signifying BOD are moving into the final recruitment of last patients).

A total of 370 patients have been screened, with the company on track to meet their recruitment target of 198 by the end of Mar.

In order to ensure a consistent patient base for the study and minimise variation, potential patients have undergone rigorous screening, the company stated.

Trial results have been collected as both qualitative and quantitative data and through utilising technology involving smart watches to enable more efficient data collection.

On completion of the data capture from the last patient, the trial focus will immediately move to the analysis of the data.

BOD says that it will have sufficient data to progress to a registration under Schedule 3 for a low dose CBD product with the TGA.

In preparation for this, BOD is compiling the Registration Dossier in parallel with the trial progression, and therefore it says it is well advanced for submission to the TGA.

The clinical trial was a double-blind, randomised and placebo-controlled investigation of the effect of administering 50mg and 100mg oral doses of a proprietary CBD product per day versus a placebo.

BOD's CBD formulation is presented in a soft gel format and utilises a patent protected encapsulation technology that improves the bioavailability of the CBD extract.