CT Pharma, a Connecticut-based medical marijuana production and research company, made history in 2019 when the U.S. Drug Enforcement Administration allowed it to grow marijuana for FDA-approved research. It became the first state-licensed cannabis company that could legally provide cannabis for studies funded by the federal government, breaking the University of Mississippi’s monopoly on cultivating research-grade cannabis.
The university had been the only federally approved supplier of cannabis for years. Still, researchers regularly complained that the cannabis produced by the facility was low-grade and compromised the results of their studies.
In a move that is sure to be approved by the cannabis research community, CT Pharma is now partnering with Yale University to produce cannabis for research on whether cannabis-derived tablets can be effective treatments against pain and stress. Researchers from Yale University will use cannabis flower cultivated in CT Pharma’s Rocky Hill, Connecticut facility. The company’s president, Rino Ferrarese, said that this federally funded study will leverage plant material cultivated within a state-level medical program, making it unique compared to other cannabis studies.
Ferrarese is also the executive vice president of the north region for Verano Holdings, an Illinois-based company that recently acquired CT Pharma. In early 2020, he predicted that this study would end in the creation of an FDA-approved, cannabis-derived tablet that could be on the market as soon as 2025. He stated that the federal agency had finally “opened up” and no longer took decades to approve new therapies.
Ferrarese believes that the FDA is interested in approving more effective treatment therapies sooner but noted that both patients and the industry as a whole would benefit from being slow and meticulous.
Even so, obtaining FDA approval for the study was far from easy. According to Ferrarese, the FDA was particularly interested in seeing if CT Pharma’s cannabis was cultivated, extracted, manufactured and packaged under Good Manufacturing Practice Standards. The agency requested the cleaning logs, facility layout and cultivation batch records. Furthermore, CT Pharma was required to provide potency, microbiology and stability tests to prove that the cannabis biomass was not contaminated.
All in all, the agency asked CT Pharma for “reams and reams of information,” Ferrarese said, including analytical reports, master batch records, facility control documentation and training records for all facility staff.
Yale University of Medicine professor Ranjita Sinha is in charge of the study and has already made some headway in the pain-management study. Her team discovered that a 40 mg CBD tablet with a low-THC dose and a 100 mg CBD tablet with little THC are reasonably efficient at alleviating pain.
As more research entities gain access to research-grade cannabis, which is representative of the marijuana products that consumers buy from state-legal sources, the public is bound to obtain a deeper understanding of how the products of regulated companies such as Prime Harvest Inc. can impact their health for the better and any drawbacks to such cannabis use.
NOTE TO INVESTORS: The latest news and updates relating to Prime Harvest Inc. are available in the company’s newsroom at https://cnw.fm/PRIME
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