A CBD soft gel capsule which Bod Australia hopes to launch as an over-the-counter product will initially be made available through the Special Access Scheme (SAS) next month.
The medicine, Bod Bio-Absorb 100, will sit under its MediCabilis brand and will be the company’s fourth product sold through the SAS.
But Bod’s announcement raised eyebrows, with its statement to the ASX declaring it was launching a “low-dose CBD schedule 3 product via [the] SAS-B channel”.
No CBD products have yet been approved for S3 registration, prompting Medlab head of pharmaceuticals Tony Potter to describe the announcement as “misleading”.
“It is not S3 until it has been reviewed and approved by [the] TGA and is listed on the ARTG,” Potter wrote on LinkedIn.
Bod said the Bio-Absorb 100 product is the focus of a phase II clinical trial which, if successful, will help it achieve S3 registration with the TGA. The trial will investigate the efficacy of the medicine on symptoms associated with insomnia.
Bod chief executive Jo Patterson said: “The launch… provides Bod with another product in the Australian medicinal cannabis market which has the potential to increase sales and brand awareness.
“Importantly, the introduction of the product through prescription channels will also provide us with valuable feedback as we continue our clinical trial and endeavour to launch Bio-Absorb 100 through the Australian pharmacy market in the coming months.”