Following last month’s disastrous news that a cannabidiol (CBD) acne trial failed, Botanix (ASX:BOT) may win back doubters after convincing the DEA to de-schedule synthetic CBD.

The Drug Enforcement Agency (DEA) has removed the synthetic CBD made by Georgia-based Purisys from its druge schedule, and told the two companies on Friday it would no longer be scheduled as a controlled substance at all, because it could prove it effectively contains no THC.

Before now companies using synthetic or natural CBD needed licences from the DEA for all aspects of logistics and use, and cross-border transport was tightly controlled.

Stockhead understands this change is only for Purisys and is not an industry-wide shift in position from the DEA.

The company says the change will “greatly reduce” its costs.

The US drug law enforcer moved in late 2018 to re-schedule CBD generally from category 1 (in with cocaine and heroin) to category 5, meaning it considers the substance to have some medical benefit but is open to abuse.

Botanix signed with Purisys in October to supply all of the synthetic CBD it needs.

Also in October, Botanix said its acne trial failed: the 368 patient trial of BTX 1503 only worked for 40 per cent of cases, which isn’t better than current non-CBD drugs on the market.

To be commercialised, drugs have to be better, not just the same.


In other ASX health news today:

Kazia Therapeutics (ASX:KZA) may be able to give glioblastoma (brain cancer) sufferers three more months of life with its drug, but can’t be completely sure yet because that’s based on data from the first eight patients with viable data, in a 29-patient phase two clinical trial. They do not yet have an overall survival rate.

Cynata (ASX:CYN) has applied for permission to start a phase two trial on critical limb ischaemia, a disease that involves the narrowing of arteries in the limbs. It generally results in amputations and is a risk factor for heart attacks. The company wants to test its Cymerus mesenchymel stem cell treatment on it.