CT Pharma uses FDA approval to provide cannabis for Yale University research studies

Connecticut-based CT Pharma, one of the four original companies to receive medical cannabis cultivation licenses in the state, made headlines in 2019, when it became the first state-licensed operator approved by the U.S. Food and Drug Administration to grow cannabis to be used in an FDA-approved study.

Until then, the cannabis flower and oil used in FDA-approved studies had been grown at the University of Mississippi (the sole federally approved grower in the United States until recently), produced synthetically or imported.

CT Pharma is collaborating with the Yale University School of Medicine on the study, which explores the efficacy of cannabis-derived tablets to treat stress and pain. Tablets are made from cannabis flower produced at the firm’s facilities in Rocky Hill, Connecticut.

“The fact that we’re using material from plants grown within a medical program at a state level (for a federally approved study), that’s what makes it unique,” said Rino Ferrarese, CT Pharma’s president as well as executive vice president of the north region for Illinois-based Verano Holdings. A Chicago-based multistate operator, Verano acquired CT Pharma in late 2021.

When interviewed by MJBizMagazine in early 2020, Ferrarese predicted that the study would result in an FDA-approved tablet that would be on the market by 2025. The COVID-19 pandemic greatly delayed the study, but researchers finished the first phase and are now recruiting subjects for the second.

Asked whether he still believes CT Pharma could have an FDA-approved cannabis-based pain reliever on the market by 2025, Ferrarese said, “Anything is possible.

“The reality is that the FDA has opened up. The days of the FDA taking 20-plus years to approve a drug are behind us,” Ferrarese added. “I think that the FDA wants to approve better medicines quicker.”

But, he added, taking the time to navigate a process as rigorous as an FDA study will benefit consumers and the industry.

“There are tons of anecdotal stories of patients responding favorably to cannabis as medicine. But when you get into a clinical setting where … you’re using analytical methods to evaluate responses from the subject, it’s not until you start pulling all of these pieces together that you can start making inferences and really determining if, in fact, it’s efficacious,” Ferrarese said.

A licensee OK’d by Feds

Rajita Sinha, a Yale University School of Medicine professor, wanted to use CT Pharma’s cannabis in research studies, and Ferrarese believes the company’s relationship with Sinha convinced the FDA to approve the partnership.

Sinha already had developed and tested cannabis formulations for FDA-approved studies. And the FDA was more concerned about whether CT Pharma adhered to current Good Manufacturing Practice standards, Ferrarese said – specifically its cultivation, extraction, manufacturing, packaging and other processes.

The FDA wanted to see cultivation batch records, cleaning logs and facility layout. The agency also requested microbiology, potency and stability results showing that biomass didn’t become contaminated over time.

“You need master batch records, training records for all of the staff, facility-control documentation, analytical reports. We had all of that on hand and were able to provide it to the FDA,” Ferrarese said.

While the FDA requested “reams and reams” of information from CT Pharma, no one from the company had to meet with FDA officials, leaving the discussions to Sinha and other Yale researchers.

Study updates

Despite COVID-19 delays, Sinha and her team finished the first pain-management study, which identified two specific dosages that met the team’s expectations for efficacy. Those two doses – one, a tablet containing 40 milligrams of CBD plus a low dose of THC; the other, a tablet with 100 milligrams of CBD plus a low dose of THC – will be the basis of the next study.

“We were evaluating patients for the effect of cannabis as natural medicine on their subjective and physiological response to stress and pain,” Ferrarese said.

The first study involved subjects 21 to 45 years old. Over a six-week trial, subjects were given six doses – two CBD only and three combinations of CBD and low-dose THC, plus a placebo – to see how they reacted when subjected to pain and stress.

To do this, researchers put subjects through a so-called “cold pressor test,” in which individuals who have taken a dose (or placebo) submerged their hands in ice water. Researchers then drew blood to evaluate certain markers to see if the cannabis tempered physiological responses of pain and stress.

In the second study, for which Yale will soon be recruiting, researchers will test the two dosage forms on subjects 21-60 years old with chronic pain. They’ll dose every day and complete laboratory and blood analyses on days one, three and seven, when researchers look for markers that could suggest therapeutic effect.

Future tense

Ferrarese believes it’s inevitable that the DEA will approve more state-licensed companies to provide cannabis for research – and not just university studies.

Ferrarese said academia is not set up to run large-phase clinical trials on human volunteers. Instead, commercial research organizations (CROs), are better designed for administering studies. For example, they are faster at recruiting and enrolling subjects, he added.

“Once we start seeing that the rules are loosening up a little bit and cannabis companies like ours are allowed to start exploring research and partnerships with CROs, we’ll get to the science that much sooner,” Ferrarese said.

“Developing cannabis drugs is a slow and tedious process right now because of all the restrictions that are in place. As the government comes around … we’ll be able to pursue commercially more accelerated pathways forward in developing the science.”

Source: https://mjbizdaily.com/ct-pharma-fda-approved-cannabis-research-yale-university/