ARTICLE LINK: http://www.pharmtech.com/us-regulators-permit-kannalife-sciences-import-cannabidiol-feasibility-studies
The US Drug Enforcement Agency (DEA) has granted permission for the import of pharmaceutical-grade cannabidiol to Catalent Pharma Solutions for a feasibility study in conjunction with Kannalife Sciences, according to a company press release. Upon completion of the feasibility study, Kannalife will investigate the product’s ability to treat hepatic encephalopathy and chronic traumatic encephalopathy, which are neurodegenerative conditions. Additional research and development for the drug candidates will occur at The Pennsylvania Biotechnology Center in Doylestown, PA, and in other contract manufacturing facilities designated by Kannalife’s scientific team.
Kannalife’s research is bolstered by two licenses from the National Institutes for Health for a patent “Cannabinoids as Antioxidants and Neuroprotectants.” Specifically, the patent, licensed by Kannalife, claims cannabidiol could be used to prevent “glutamate-induced damage in the central nervous system,” among other things. The company’s specific product of interest, KLS-13019, is a novel cannabidiol-like therapeutic compound that is being investigated as a possible treatment for oxidative stress-related diseases.
Kannalife teamed up with Catalent to conduct feasibility studies to investigate shelf stability and dose-dependent administration of the cannabidiol drug target being formulated for the company’s cannabinoid-derived therapeutic agent. The information gleaned from the feasibility studies will help Kannalife further its preclinical development of the target drug candidate and the company’s filing of an investigational new drug (IND) application for clinical studies in humans.
The cannabidiol procured by Kannalife, which itself has no psychoactive effect, is a synthetic white solid that is not naturally derived, Kannalife CEO, Dean Petkanas, told BioPharm International. The sources for this synthetic product within the United States were limited, he noted, and the company needed a large quantity of this raw API to conduct feasibility studies. Although Petkanas said there were a few potential suppliers in the US, “capacity was constrained,” and therefore, the synthetic product had to be imported from a supplier outside of the country.
Similar cannabis-based formulations and structural analogs of cannabidiol by other drug companies are currently in development for the treatment of other chronic conditions. One such company recently in the news is GW Pharmaceuticals. The combination of research on cannabidiol oil by GW and the company’s IND applications, coupled with the medical claims of online companies marketing and selling CBD oil, prompted FDA to send warning letters to these online merchants in early February 2016. Because CBD oil is being examined for its medicinal properties in an IND, it cannot be considered a dietary supplement—and thus, cannot be sold online under these pretenses, the FDA said in the warning letters.