Marijuana Business Magazine April 2020

April 2020 | mjbizdaily.com 79 CT PHARMA’S CANNABIS-TO-TABLET BREAKTHROUGH CT Pharma is collaborating with the Yale University School of Medicine on a new study exploring the efficacy of cannabis- derived tablets to treat stress and pain. Notably, the tablets will be made from cannabis flower produced at the firm’s facilities in Connecticut. CT Pharma Chief Operating Officer Rino Ferrarese said that, to his knowledge, this is the first time cannabis grown by a state-licensed producer in the United States has been used in an FDA-approved study. Until now, the cannabis flower and oil used in FDA-approved studies have either been grown at the University of Mississippi (the sole federally approved grower in the United States), produced synthetically or imported. CT Pharma was founded in 2014 with pharmaceutical ambitions. Not satisfied with being a license holder in a limited market, CT Pharma’s leaders dispatched ambassadors to international cannabis science conferences while networking in a local landscape rich with universities, hospitals and pharmaceutical companies. That networking led them to Dr. Rajita Sinha, a Yale University School of Medicine professor who already had done clinical trials with cannabinoids and had past successes getting study approval from the Institutional Review Board (IRB) of the Yale medical school. An IRB, found at many research institutions, must approve a researcher’s study proposal before it can be submitted to the FDA for consideration. “Meeting someone with experience getting cannabinoid formulations through IRB to approval—that was a really big deal,” Ferrarese said. CT Pharma started with an oral spray formulation that the FDA approved for study in 2017. But after several months, researchers decided that oral sprays were less than ideal for patients and health providers and tablets were deemed a better choice. WHAT THE FDA WANTS TO SEE While CT Pharma had produced thousands of cannabis tablets in its facilities and had extensive safety and efficacy records, Sinha wanted to work with tablets of different ratios—10 milligrams of THC and 40 milligrams of CBD, for example—which required CT Pharma to run a new battery of tests relating to safety, contaminants, packaging, stability and degradation. Because the FDA was familiar with the cannabinoid formulations developed by Sinha, the agency already knew they were safe to be tested on human subjects. The FDA was more interested in CT Pharma’s cultivation, extraction, manufacturing and packaging processes—namely, ensuring that they are performed under current Good Manufacturing Practice. “They wanted to see our batch records for our cultivation processes; they wanted to see our cleaning logs, our facility layout. That’s what they wanted from us as a manufacturer,” Ferrarese said. “To get what they needed, they requested potency and stability results. They wanted to see microbiology results (showing) that it didn’t become contaminated over time. But really they were worried about degradation and contamination, namely purity and quality.” “What happens to this tablet after six months, after a year? Is it still the potency that we formulated? Because that’s going to impact the patient’s experience and the study outcome. We had to make sure that each formulation in the study was standardized and consistent. Compiling all the information and documentation took about a year. It took the FDA about four to six weeks to come back and say, ‘Your study may proceed,’” Ferrarese said. CT Pharma did this for both the spray and the tablets, he added. While the FDA requested “reams and reams” of information from CT Pharma, no one from the company had to meet with FDA officials; that left the discus- sions up to Sinha and other Yale research- ers. In early November 2019, subjects were recruited for the study, which was Interventional vs. Observational Studies Observational Study A clinical study in which participants identified as belonging to study groups are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic or other types of interventions, but the investigator does not assign participants to specific interventions (as in an interventional study). These studies do not lead to new drug approvals. Interventional Study A clinical study in which participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study protocol. Participants may receive diagnostic, therapeutic or other types of interventions. These studies can lead to new drug approvals. Source: National Institutes of Health Dr. Rajita Sinha