Botanix Pharmaceuticals has announced that the US Drug Enforcement Administration (DEA) has advised Botanix’s partner Purisys, that synthetic cannabidiol (CBD) produced by them, and used by Botanix, is no longer scheduled as a controlled substance.
"On Friday 22 November, advice has been received from the DEA that confirms Purisys’ ultra-high purity synthetic cannabidiol CBD (which has a specification that it contains less than 0.001% THC) has been removed from Schedule 1 of the Controlled Substances Act, along with all degradants, metabolites and analytical reference standards related to synthetic CBD," the team with the company explains.
Prior to the DEA’s advice, all usage of synthetic CBD, including manufacturing, storage shipping and conduct of clinical and non-clinical studies required express approval and licenses from the DEA. "This presented significant management and cost overheads to Botanix’s pharmaceutical development activities," they further explain. "For example, all clinical investigators involved in Botanix studies of its dermatology products in the USA were required to maintain licenses and physical safes to store clinical study materials. As a result, transport across State and international borders was extremely tightly controlled, with reimport of CBD into the USA not being permitted."
Executive Chairman and President, Vince Ippolito, commented: “This change in the regulation of synthetic CBD in the US will make a major difference to the speed of developing Botanix products and greatly reduces the risks and costs of clinical development.”
“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 (regardless of DEA license status) is greatly enhanced. The change in regulation has come at a favourable time, where the Company is actively preparing for large late-stage studies across our dermatology programs.”
In October, Botanix signed a supply agreement with Purisys which covers Botanix’s requirements for immediate clinical and future commercial supplies of synthetic CBD. The agreement commits Botanix and Purisys to collaborate in relation to 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 continue to create increased value for both companies as the manufacturing process for CBD and raw material savings are realised.
Jim Mish, CEO of Purisys, commented: “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. At Purisys, we stand ready to back this research, with our applications support, analytical reference standards and cGMP manufacturing. This is further backed by our world-scale supply capability for commercial production.”
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