October 2nd, 2020
Conor O’Brien
Source: Therapeutic Goods Administration, Prohibition Partners
The Australian Therapeutic Goods Administration (TGA) approved just over 6,200 applications for access to medical cannabis products in September via the SAS-B pathway, bringing the quarterly total to 14,327 and yearly total to 35,428 compared to just 13,799 for the same time last year. This growth in the midst of COVID-19 can be attributed in part to increased access to telemedicine appointments with doctors, which have been rolled out across the country in response to the lockdown.
These approvals should not, however, be taken as a precise measure of patient numbers, as certain patients are not accounted for, such as those accessing medications via Authorised Prescribers or pharmacy compounding, and also these figures do not account for patients who stop using these medications.
This news of growth is just the latest in a string of relatively positive developments for Australian cannabis stocks amidst the turmoil of COVID-19 and lab testing issues. Zelira Therapeutics’ treatment for insomnia, ‘Zenivol’, recently received TGA approval for patient access via special access schemes. GW Pharmaceuticals scored another approval as the TGA approved the use of Epidiolex for epilepsy due to Dravet and Lennox-Gastaut syndromes. Epidiolex will join Sativex as the only cannabis medications on the Australian Register of Therapeutic Goods (ARTG).
Potentially massive news for the industry is that the TGA has backed the sale of CBD products as over-the-counter medications (OTC). This would open up patient access for these medicines as a costly doctor’s visit would no longer be necessary. Any CBD product which could be sold OTC would still need to pass rigorous pharmaceutical regulatory approval by the TGA before being marketed. Furthermore, no more than 60mg per day can be recommended on packaging, which falls below the current dosages of many therapies. The TGA is expected to give its final decision on OTC CBD medications by the end of next month.
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