The Therapeutic Goods Administration (TGA) has announced a significant change in its final decision to down-schedule low-dose CBD, with the maximum dose increased to 150mg/day, up from the 60mg/day it signalled in its interim decision in September.
The move follows further consideration of safety information, public submissions on the interim decision and the advice of the Joint Committee of the Advisory Committees for Medicines Scheduling and Chemicals Scheduling at its November 2020 meeting.
The industry had raised concerns about its ability to demonstrate efficacy at 60mg/day when the interim decision was announced.
The move will allow low-dose CBD-containing products, up to a maximum of 150 mg/day, for use in adults that have been approved by the TGA, to be supplied over-the-counter by a pharmacist, without a prescription.
The decision limits over-the-counter supply to products that are approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG). The decision also outlines additional limits on dosage form and packaging requirements, including pack size and child resistant closures.
There are currently no TGA approved products on the ARTG that meet the Schedule 3 criteria.
The move has been welcomed by industry leaders, although some warned of the challenges ahead.
FreshLeaf Analytics managing director Cassandra Hunt said: “History suggests that the first movers among product companies will be the winners, with the first movers in the medicinal cannabis industry in Australia still dominating today.
“The race is now on to get products in the market as quickly and cost effectively as possible, assuming companies are able to overcome the challenge of proving efficacy.”
Applied Cannabis Research advisory board member Dr Melissa Benson agreed there are still some hurdles for companies to jump: “The current registration pathway for Schedule 3 requires efficacy data, which helps support further clinical research in the area of low-dose CBD medicines. This may, however, be challenging to produce at a low dose.
“Nonetheless, if fewer consumers seek out illicit CBD products which have unknown content/quality, then this move ultimately promotes greater safety for patients, which has to be the priority.”
Medical director and addiction specialist at CA Clinics Dr Mark Hardy added: “This could potentially result in more Australians benefiting from the therapeutic properties of cannabis. However, the effects of low-dose CBD may be negligible for many chronically ill patients.
“Pharmacists would also still need to consult with consumers to ensure they’re aware of potential drug-drug interactions, as CBD can affect the way certain other medications are metabolised. Bottom line, consumers should consult their GP before taking over-the-counter products.”
Sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG.
Melbourne-based medicinal company Entoura, which currently has three products in market that fit the Schedule 3 profile, said it will apply for ARTG registration for all of them to be available over the counter.
However, general manager Clare Barker urged consumers to be patient: “With the submission requirements and TGA review timelines, there are unlikely to be Schedule 3 product options available for Australian consumers until 2022,” she warned.