Connecticut Pharmaceutical Solutions (aka CTPharma), a medical cannabis producer in Connecticut, today announced “groundbreaking” Food and Drug Administration (FDA)-approved clinical studies to study stress and pain relief in human patients.
During a press conference in the Beaumont Room at the Yale School of Medicine, company co-founders Tom Schultz and Rino Ferrarese (also Cannabis Business Times columnists) stood next to Connecticut Department of Consumer Protection Commissioner Michelle Seagull, school administrators and medical researchers in launching the company’s Investigational New Drug (IND) clinical study. The first phase of the study is focused on safety and dosing in treating those symptoms. The study will be the first of its type on human subjects, according to CTPharma: a double-blind, randomized, placebo-controlled clinical study using medical marijuana with an FDA-approved protocol.
“America has set the world’s pharmaceutical standards for the past century,” Ferrarese said in a statement to CBT. “Today, an English company has the only FDA-approved plant-based medical marijuana product in our pharmaceuticals market. CTPharma has the knowledge and discipline to use plant-derived cannabinoid formulations and to prove their safety and efficacy to any standards, including the FDA’s.”
This announcement has been two years in the making, as CTPharma and Yale began the IND study application process in 2017.
Before conducting human tests with a non-FDA-approved drug, researchers must submit an application. According to the FDA, an IND application “includes protocols describing proposed studies, the qualifications of the investigators who will conduct the clinical studies, and assurances of informed consent and protection of the rights, safety, and welfare of the human subjects. The FDA reviews the IND to ensure that the proposed studies, generally referred to as clinical trials, do not place human subjects at unreasonable risk of harm. The FDA also verifies that there are adequate assurances of informed consent and human subject protection.”
“The research that we’re talking about today will prove that CTPharma, along with Yale, has the ability to use plant-based cannabinoid formulations and to prove their safety standards in an FDA study,” said Michael Fedele, Chairman of the CTPharma Board of Directors, at the Yale School of Medicine event.
Part of the research will be directed by Dr. Rajota Sinha from the Yale School of Medicine. “My work has been at the intersection of stress, trauma, addiction and chronic illnesses,” Sinha said at the press conference. “We’ve been looking at mechanisms both in developing new treatments for these types of symptoms and specific addictive disorders, as well as understanding how these drugs are acting in the body. It’s a nice extension for us: we want to understand the positives and the negatives, we want to understand where we can capture therapeutic potential and translate that into treatments and preventions. We’re really glad to get to this point with this class of products.”
Patients looking to participate must be registered with the Connecticut medical cannabis program. Indeed, CTPharma hopes this study places the state on the cannabis biotech map.
“There is significant biotechnical interest in research related to medical [cannabis] and I believe that significant biotechnical industry will grow right here in Connecticut because of this type of study that is going on,” Fedele said. “We at CTPharma hope to see a big share of that biotechnical industry right here in Connecticut, along with the economic growth and jobs that come [with it].”
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