- Purisys, a partner of Botanix Pharmaceuticals (ASX:BOT), has been informed its synthetic CBD is no longer a controlled substance
- This significantly reduces costs surrounding manufacturing, shipping, storing and running studies
- Before the DEA’s advice, all usage of synthetic CBD required approval and licences
- In light of this news Botanix is up a slight 2.38 per cent with shares trading for 10.8 cents each
Purisys, partner of Botanix Pharmaceuticals, has been advised by the U.S. DEA that its synthetic cannabidiol (CBD) is no longer a controlled substance.
On November 22, Purisys announced that advice had been received from the DEA (Drug Enforcement Administration) that confirmed its ultra-high purity synthetic CBD has been removed from the Schedule 1 of the Controlled Substances Act.
Metabolites, degradants and analytical reference standards relating to synthetic CBD were also removed.
Before the DEA’s advice all usage of synthetic CBD, including shipping and clinical and non-clinal studies, required approval and licences from the DEA.
This presented significant management and cost overheads to Botanix’s pharmaceutical development activities.
Therefore, all clinical investigators involved in Botanix studies of its dermatology products in the U.S. were required to maintain licences and physical safes to store clinical study materials.
As a result, transport across State and international borders was tightly controlled with reimporting into the U.S. not being permitted.
Executive Chairman and President of Botanix Vince Ippolito couldn’t be more pleased with the outcome.
“The change in the regulation of synthetic CBD in the U.S. will make a major difference to the speed of developing Botanix products and greatly reduces the risks and costs of clinical development,” Vince said.
“The ability to manufacture at one site and distribute nationally and internationally means our supply chain is significantly simplified and our ability to recruit the best clinical sites is greatly enhanced,” he added.
This change comes at a time when Botanix is preparing for large late-stage studies across its programs.
In October, Botanix signed a supply agreement with Purisys which covered Botanix’s requirements for immediate clinical and future commercial supplies of synthetic CBD.
This agreement committed Botanix and Purisys to collaborate in setting future volume requirements and manufacturing scale up and optimisation.
Botanix was able to secure preferential pricing for its synthetic CBD requirements as well as a commitment to work with Purisys to create increased value for both companies as the manufacturing process for CBD is realised.
“Now that our CBD products are no longer subject to DEA Schedule 1 status, our pharmaceutical customers are able to more easily conduct research that will be important to the use of cannabinoids in a wide range of products,” Jim Mish CEO of Purisys commented.
Botanix has also recently completed its BTX 1503 acne patient phase 2 study and is preparing for an end of phase 2 meeting with the FDA (Food and Drug Administration).
The company also has a phase two study in atopic dermatitis (eczema) in late stage enrolment and plans to begin two additional studies in the coming months.
In light of this news Botanix is up a slight 2.38 per cent with shares trading for 10.8 cents apiece at 12:32 am AEDT.