
US Regulators Permit Kannalife Sciences to Import Cannabidiol for Feasibility Studies
The US DEA will allow Kannalife access to pharmaceutical-grade cannabidiol to conduct feasibility studies for a potential treatment for neurodegenerative diseases.
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,
Kannalife’s research is bolstered by two licenses from the National Institutes for Health for a
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
Source: Kannalife
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