Medical dermatology company Botanix Pharmaceuticals (ASX:BOT) has secured a supply of synthetic cannabidiol, which has been manufactured at commercial scale by its US-based partner.
According to the company, unlike cannabidiol sourced from natural extracts, pharmaceutical grade synthetic cannabidiol (referred to chemically as 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol) is of high purity and does not vary in strength or composition due to growing conditions, genetics of the source plant, or the extraction and purification processes that must be used to separate natural cannabidiol from the hundreds of other chemicals found in the plant.
This represents a significant advantage for Botanix products, said the company, as it will not be required to comply with the extensive testing and controls in the US FDA’s 'Guidance for Botanical Drug Products' that apply to natural cannabidiol extract based products.
"The challenge of complying with this Guidance is evidenced by the fact that there are currently no FDA registrations of a cannabidiol drug substance which has been sourced from natural extracts, and manufactured at commercial scale," it said.
“This is an important milestone in the development of an acne treatment that can be FDA approved and supplied commercially,” said Botanix Executive Director Matt Callahan.
“Our use of synthetic cannabidiol substantially increases the likelihood that Botanix products can satisfy the stringent FDA requirements for purity and consistency and avoids the risks associated with natural extract based products.
“Just like the earliest forms of Aspirin were extracted from the bark of the Willow tree,” added Mr Callahan. “Today we wouldn’t think of using a natural extract when we can chemically synthesize pure Aspirin at industrial scale for pain relief. The use of cannabidiol for pharmaceutical treatments needs to go the same way and Botanix are leading that development with our skin disease products.”
The commercially synthesized cannabidiol will be used in Botanix’s lead development program for the treatment of acne, BTX1503. Botanix’s approach of using a drug substance which is already filed with FDA and has achieved high quality and purity standards, satisfies an important hurdle for the eventual FDA approval of the Company’s BTX1503 acne product.
The company said it plans to advance the first of its products for the treatment of acne into clinical trials in humans in Australia in early 2017. It is actively exploring opportunities to leverage its skin delivery technology and growing team to rapidly advance other products into the clinic.