Cultivation
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/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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